**Job Title:** Area Business Manager - Indianapolis **About the Job** The **Area Business Manager (ABM)** is responsible for engaging Dermatologists and other key customers within an assigned geography ( **Indianapolis, IN** ) and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to Atopic Dermatitis, Chronic Spontaneous Urticaria, Prurigo Nodularis, and Bullous Pemphigoid. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US.
We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
**Main Responsibilites:**
+ Engage Dermatology/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and other dermatological indications.
+ Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography.
+ Develop strong working relationships with Dermatology experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed.
+ Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business.
+ Plan, organize, and execute local promotional speaker programs and activities.
+ Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business.
+ Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences).
+ Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results.
+ Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value.
**About You**
+ Bachelor's degree from an accredited four-year college or university.
+ 3+ years of pharmaceutical, biotech, or medical device sales experience.
+ Demonstrated ability to learn and apply technical and scientific product-related information.
+ Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory.
+ Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines.
+ Ability to operate as a "team player" in cooperation with collaboration partners and internal colleagues to reach common goals.
+ Valid Driver's License.
**Preferred Qualifications:**
+ 2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics in a complex and competitive market.
+ 2+ years selling experience in dermatologic disorders such as atopic dermatitis strongly preferred.
+ 2+ years selling experience calling on Dermatologists.
+ Launch experience in specialty care and biologics strongly preferred.
+ Alliance/matrix partnership experience strongly preferred.
+ Demonstrate advanced clinically based selling skills.
+ Results oriented with a proven track record of success with product launches.
+ Experience with in-servicing and training office staff, nurses and office managers.
+ Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends.
+ Highly organized with strong account management skills.
+ Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SG
\#LI-GZ
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
_North America Applicants Only_
The salary range for this position is:
$123.750,00 - $178.750,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* .
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
$123.8 hourly 60d+ ago
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Area Business Manager - Allergy - Indianapolis, IN
Sanofi 4.3
Sanofi job in Indianapolis, IN
Job Title: Area Business Manager - Allergy - Indianapolis, IN
About the Job
Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Sanofi Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases, oncology, immunology and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine.
The Area Business Manager (ABM) is responsible for engaging Allergists, and other key customers within an assigned geography and presenting clinically focused selling messages to create and grow revenue and to consistently deliver product goals related to atopic dermatitis and asthma indications. The ABM will demonstrate initiative, drive, independence, and take ownership for meeting and exceeding individual business goals. This will be accomplished by driving performance and delivering results in a compliant manner with a high degree of integrity strictly following all Sanofi US policies and in compliance with all policies and procedures governing the promotion of pharmaceutical/biological products in the US.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
Engage Allergy/Immunology customers within assigned geographical territory and deliver clinically focused message to introduce, launch, grow brand-share and revenue and to consistently deliver on product goals for atopic dermatitis and asthma indications.
Collaborate and coordinate with other key field-based stakeholders such as Regeneron Sales Professional counterparts, Medical Science Liaisons, Field Reimbursement and Market Access teammates, Thought Leader Liaisons, and others in their territory to proactively address customer needs, identify market dynamics and trends, develop strategies which support brand and corporate objectives, and ensure optimal account success within their assigned geography.
Develop strong working relationships with Allergy experts in assigned geography as well as biologic coordinators, office staff and other important health care personnel and key patient advocacy support groups as directed.
Drive results by identifying key opportunities and developing strategic business plans to generate product utilization and grow territory business.
Plan, organize, and execute local promotional speaker programs and activities.
Maximize budget allocated to the geographic territory to support execution of strategies and tactics and generate/grow the business.
Participate and help lead initiatives to support sales success as assigned (e.g. participate in industry related congresses, local and regional meetings and medical conferences).
Own business opportunities within respective geographic area, which includes coordination and calling upon large group practices and other key targets to drive overall product results.
Establish relationship with thought leaders in assigned territory. Primary objective is to drive industry leading customer value.
About You
Basic Qualifications
Bachelor's degree from an accredited four-year college or university.
3+ years of pharmaceutical, biotech or medical device sales experience.
Demonstrated ability to learn and apply technical and scientific product-related information.
Ability to travel to meetings/trainings/programs as necessary - additional travel may be required within the assigned territory.
Proven success and positive track record of consistent sales performance in complex markets with diverse customer segments operating with a high degree of integrity within compliance guidelines.
Ability to operate as a “team player” in cooperation with collaboration partners and internal colleagues to reach common goals.
Valid Driver's License.
Preferred Qualifications
2+ years selling sub-cutaneous self-injectable (or office administered IV) biologics.
2+ years selling experience in Asthma or other Immunology disorders strongly preferred .
2+ years selling experience calling on Allergists.
Co-promotion experience preferred.
Demonstrate advanced clinically-based selling skills.
Results oriented with a proven track record of success with product launches.
Experience with in-servicing and training office staff, nurses and office managers.
Demonstrate a passion and learning aptitude for science and is proactive in strengthening knowledge related to disease-state, treatment options and healthcare trends.
Highly organized with strong account management skills.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
This position is eligible for a company car through the Company's FLEET program.
Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Remote
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$123,750.00 - $178,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
$123.8k-178.8k yearly Auto-Apply 60d+ ago
Advisor - Downstream Tech Services
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
This position is part of the Bioproduct Research and Development (BR&D) organization within Lilly Research Labs. The BRD Clinical Trial (CT) manufacturing facility is focused on bringing new protein therapeutics to market by producing bulk drug substance (DS) for clinical trials, along with the associated technical data and documentation to support GMP activities.
The Bioprocess Operations team within BR&D is responsible for the manufacture of DS to support clinical trials within the Lilly portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates, and adeno-associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. This role serves as the Technical Lead for the Downstream Tech Service and Manufacturing Science (TS/MS) team within the BR&D DS CT manufacturing facility. You will combine technical leadership with strategic execution-driving DS batch technology transfer and delivery, ensuring robust clinical manufacturing performance, and acting as a key technical interface across development, operations, automation, and maintenance teams. In addition, you will mentor and develop downstream team members, fostering a culture of technical excellence and continuous improvement.
Responsibilities:
In this role, you will provide oversight of downstream processes for Bulk DS production and lead initiatives that enhance plant performance and reliability. You will partner closely with cross-functional teams to resolve complex technical challenges, implement innovative solutions, and ensure seamless integration of development-stage technologies into clinical manufacturing. Your leadership will extend beyond technical execution to include coaching and developing talent within the team. Responsibilities will include:
Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing
Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review of executed batch records where applicable
Ensure robust execution of DS batches with adherence to quality and regulatory standards
Active oversight of process and equipment performance, troubleshooting, optimization and real-time data monitoring
Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant
Drive alignment between process development and manufacturing execution
Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations
Actively engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges.
Coach and mentor team, fostering technical growth and professional development
Promote a culture of collaboration, accountability, and operational excellence
Basic Requirements:
PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience OR
MS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 5 years hands-on purification experience OR
BS in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 8 years hands-on purification experience
Proficiency with UNICORN software for chromatography process control and data analysis
Demonstrated ability to lead cross-functional projects and mentor technical staff
Excellent communication and leadership skills, with the ability to influence and drive change
Additional Preferences:
Understanding of cGMP requirements and regulatory compliance for clinical manufacturing
Experience with scale-up of biopharmaceutical purification operations
Familiarity with automation systems and process control strategies
Understanding of computer system validation and equipment qualification
Familiarity and strong interest in application of digital solutions for GMP DS manufacturing
Additional Information:
Position located inIndianapolis, IN at the Lilly Technology Center North
8-hour days with flexibility to support activities during shutdowns, weekends, and outside of core hours
Physical Demands/Travel:
The physical demands of this job are consistent with an office and manufacturing environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position's work environment is in the office and manufacturing environment.
The
work
environment
characteristics
described
here
are
representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$129,000 - $209,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$129k-209k yearly Auto-Apply 3d ago
Process Safety Lead
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Engineering Technology Center (ETC) is a group of skilled engineering practitioners who possess deep technical expertise. The primary role of this position is to provide process safety related technical support to manufacturing. The ETC partners with manufacturing and other engineers across the company to deliver capital projects, address operational issues, and provides solutions to key business problems across the company.
Responsibilities:
This role is the Process Safety Management technical resource in the ETC.
Become a key engineering/technical resource for the GIPSM processes across Lilly such as Mechanical Integrity, Process hazards, Pressure safety, and others.
Be a corporate technical resource on pressure relief hazards.
Provide internal capability to calculate or evaluate pressure relief system sizing.
Recommend external resources for evaluation and sizing of emergency pressure relief systems.
Review third party evaluations of pressure relief system design.
Be a corporate technical resource on Mechanical Integrity
Provide technical expertise to ensure alignment with recognized engineering practices and Lilly global engineering standards
Understand critical safety system components and design to support LOPA evaluations
Provide inspection expertise with respect to technology and program setup
Support standardization of MI elements within maintenance package development
Support standardization of Asset Integrity & Repair with respect to Operational Readiness Reviews
Become engineering resource on key GPSIM processes such as Process hazards reviews, process hazard evaluations, LOPA, event investigation, etc.
Partner with GHSE on technical solutions for safety related trends and ownership of key GHSE standards and expectations
Partner with LRL colleagues on ensuring process safety related aspects are considered when developing new processes, products.
Adaptability
Flexibility in adapting and adjusting to changes in working practices and willingness to take on different roles as required by the needs of the Engineering Tech Center
Ability to work with diverse perspectives and to identify and resolve issues with minimal direction.
Basic Qualifications:
Bachelor's in Engineering (e.g. Chemical Engineering)
Minimum 8 years' experience in pharmaceutical and/or specialty chemical laboratory and/or manufacturing environments
Additional Preferences:
Professional engineering license.
Experience as a mechanical or process engineering in two or more of the following areas: small molecule bulk, large molecule bulk, dry products, parenteral products, delivery devices, utilities, facilities management, Lilly Research.
Demonstrated knowledge of US and non-US codes and standards applicable to emergency pressure relief.
Must have demonstrated good written and verbal communications skills. Demonstrated ability to work within and lead diverse, multi-functional teams (i.e. Engineering, Manufacturing Operations leadership, TS/MS, etc.).
Demonstrated project management, interpersonal and communication skills.
Ability to identify and resolve issues with minimal direction.
Demonstrated familiarity with understanding and application of common engineering specifications/standards to identify and resolve issues with minimal direction.
Must be able to work in an environment where limited or conflicting direction is given.
Qualified to perform emergency relief calculations.
Knowledgeable of first principles.
Additional Information:
ETC supports all business areas across the globe. Business travel both inside and outside the U.S. may be required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$66k-171.6k yearly Auto-Apply 24d ago
QA Associate - Visual Inspection
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
The QA Representative - Floor Support team member provides daily oversight, assistance, and guidance to issues within Parenteral Visual Inspection such as deviation investigations, change control proposals, procedure / batch record revisions, validations, batch disposition, commissioning, and qualification activities. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.
Responsibilities:
Lead, mentor, and coach Operations and support personnel on quality matters.
Ensure regular presence in visual inspection operational areas to monitor GMP programs and quality systems.
Collaborate cross-functionally as a core member of a manufacturing process team.
Assess and triage deviations that occur within the local process team.
Work with Lilly support groups and external partners to resolve or provide advice on product related issues
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
Support project and process improvement initiatives for plant Process Teams.
Basic Requirements:
Bachelor's degree in STEM related field, Engineering degree preferred.
Additional Skills/Preferences:
Previous experience in GMP production environments or Quality Control Laboratories
Knowledge and understanding of manufacturing processes and Quality Systems
Proven ability to work independently or as part of a team to resolve an issue
Strong attention to detail
Strong oral and written communication and interpersonal skills
Demonstrated decision making and problem-solving skills
Technical writing skills
Additional Information:
Travel: Less than 10%
Shift information: Day shift Monday-Friday. May be required to respond to operational issues outside of core business hours / days
Overtime may be required
Position location: LTC-South
Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$65.3k-148.5k yearly Auto-Apply 16d ago
Biologist - Neurodegeneration, Histology/Imaging
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. #WeAreLilly
Responsibilities:
Eli Lilly and Company seeks a highly motivated scientist to join our Neurodegeneration team. This position is a part of a multidisciplinary team dedicated to discovering novel medicines for the treatment of Alzheimer's disease, Parkinson's disease, ALS, and other related neurodegenerative conditions. The individual will apply cutting-edge histological and imaging techniques to support our expanding neurodegeneration portfolio. A primary focus of this position will be the establishment and utilization of imaging/histological techniques to support therapeutic investigations in multiple pre-clinical animal models.
Key Objectives/Deliverables:
* Perform histological lab techniques including, but not limited to tissue processing, paraffin embedding, tissue sectioning, routine and special tissue staining, imaging and image analysis.
* Establish and execute multiplexed immunohistochemistry (IHC) and in situ hybridization (RNAScope) to evaluate in vivo efficacy of therapeutic agents
* Contribute to development, validation, and performing advanced histological/imaging techniques like spatial transcriptomics, super-resolution microscopy, light sheet microscopy and in vivo two photon imaging
* Assist in troubleshoot technical challenges and provide scientific/technical input to project teams
* Design, execute experiments and perform data analysis
* Communicate results to the project team to drive data-driven decisions
* Provide written and verbal communication of work in lab reports and team meetings
* Accurate recording of all practical work: completion of electronic notebook to Lilly procedure quality standards
* General laboratory assistance, including ordering and receiving lab supplies, preparation of reagents, and maintain laboratory equipment
* Ensure compliance with all health and safety regulations
* Report on-site, in the lab, 5 days a week
Basic Requirements:
* BS in Neuroscience, biological sciences or related fields
* Two years of academic or industry experience with histologic analysis of animal models
Additional Skills/Preferences:
* Previous experience in neuroscience research is preferred
* Hands-on experience in autostainer (e.g. Leica Bond-RX), slide scanner imaging (e.g. Olympus VS200)
* Knowledge of relevant image analysis software packages: HALO, QuPATH and ImageJ
* Experience in stereotactic surgery and in vivo imaging is a plus
* Hands-on experience in cDNA library preparation for transcriptomics is a plus
* Ability to design, execute and interpret experiments independently
* Excellent communication skills and efficiency in collaborating across functional team
* Strong organization skills, attention to detail, critical thinking, multitasking, desire to learn new techniques and contribute to cutting-edge projects in a fast-paced working environment
Additional Information:
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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$65.3k-169.4k yearly Auto-Apply 6d ago
Engineer - TS/MS Cleaning Validation
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Brand Description:
The Technical Services and Manufacturing Sciences (TS/MS) Representative for Cleaning Validation is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support. This position focuses specifically on Dry Packaging which includes bottle and blister card filling and packaging for tablets and capsules. Primary objectives include cleaning validation, cleaning compliance, continuous improvement of processes, and supporting day-to-day operations of Process Teams.
Key Objectives / Deliverables:
Execute the technical agenda for the Dry Packaging cleaning and cleaning validation
Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
Lead technical projects to improve cleaning processes and compliance
Benchmark with sites in the network to drive technical consistency and knowledge sharing
Serve as interface with upstream suppliers and Dry product network
Own cleaning batch records and revisions, ensuring they are current and accurate
Support equipment commissioning and qualification activities, as required
Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
Understand the scientific principles required for Dry Packaging operations
Support regulatory submissions as needed
Understand and implement global requirements and standards into the Dry Process Team
Provide technical leadership for the Process Team for cleaning activities
Provide off hours support as needed
Basic Requirements:
Bachelor's degree or equivalent in a STEM discipline
Minimum 2 years of experience, with at least 1 year with cleaning/cleaning validation in a GMP environment
Additional Preferences:
Technical / Scientific knowledge of cleaning regulatory requirements and practices
Clear understanding of cGMPs
Experience in pharmaceutical manufacturing
Good teamwork and interpersonal skills
Root Cause Investigation experience
Experience in technical leadership
Oral and written communication skills that demonstrate effective communication with all levels of an organization
Other Information:
Some travel
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$66k-171.6k yearly Auto-Apply 3d ago
Advisor - Quality Audit and Compliance (Controlled Substances)
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Responsibilities:
The Advisor - Quality Audit and Compliance is part of the Global Quality Auditing and Compliance (GQAAC) division, which serves as the corporate quality auditing interface for global GxP compliance. This role focuses on Lilly‑designated Special Security Substances (SSS) and Controlled Substances (CS), ensuring processes meet company requirements, regulations, and guidelines. The Advisor provides regulatory interpretation and guidance across the product lifecycle-from discovery and development through launch, commercialization, and licensing-for all SSS and CS materials, including API, drug product, finished product, samples, and reference standards. Responsibilities include reviewing proposed CS regulations (particularly US DEA), collaborating with legal and industry groups on comments, owning and maintaining Lilly Quality Standard 303, and handling the risk assessment process for SSS designation.
The Advisor - Quality Audit and Compliance (Controlled Substances) also assures quality assurance through the execution of internal and external audits in support of pharmaceutical development and commercialization for Lilly. Through auditing, the GQAAC auditor assures that GxP operations conducted or sponsored by Lilly are performed in accordance with company standards, policies, procedures, and practices and are compliant with current regulatory requirements and expectations, applicable guidelines, and industry standards. GQAAC operates as a valued business partner by taking a proactive approach to further improving the quality status of business operations and regulatory compliance. The quality auditor plays a key part in contributing to the implementation of this strategic approach to quality auditing oversight.
Key Objectives/Deliverables:
The following activities will be performed according to current GQAAC procedures, guidelines and tools. These responsibilities are not intended to be all-inclusive:
Global SSS/CD Process Owner
Lead or participate in the preparation and review of standards, policies, procedures, and guidelines that define Quality, SSS, and CS requirements.
Build and maintain relationships with regulatory authorities; facilitate and host inspections from the US DEA, Indiana Board of Pharmacy, and other state CS agencies as required.
Maintain Power of Attorney documentation to manage DEA registrations, sign DEA Form 222, and complete required online reporting via the DEA website.
Interpret regulatory and quality standard requirements for business processes and provide guidance in response to related inquiries.
Develop or support corrective and preventive actions (CAPAs) to address gaps in SSS/CS compliance processes.
Escalate compliance issues promptly and appropriately.
Ensure adherence to applicable quality standards, manuals, policies, procedures, and tools.
Auditing Responsibilities
Interpret and apply Lilly standards, regulations, regulatory guidance, industry standards, to identify compliance risks and maintain a comprehensive knowledge of applicable regulations, technical knowledge, and training to meet the auditing responsibilities.
Lead or participate in planning, scheduling, preparing, conducting, appropriately escalating compliance issues, and reporting audits, assessments, and due diligences of GMP Operations and SSS/CD to assess the level of compliance with established standards and current regulations and guidelines.
Lead or participate in risk assessments and mock regulatory inspections of GMP Operations and SSS/CD to assess level of compliance and/or readiness to meet established standards and current regulations and guidelines, as applicable.
Provide technical input and recommendations to audit observation reports during the Audit Review Board meeting, as applicable.
Exhibit ethical behavior when auditing, including integrity, objectivity, and confidentiality, including the competency to recluse oneself from an audit when a conflict of interest or lack of competency in a specific area exists.
Exhibit interpersonal skills that are relevant to auditing, such as listening, questioning, being tactful and having appropriate non-verbal skills, handling conflict in a constructive manner and communicating (both written and verbal) in a clear and concise manner.
Exhibit skills relevant to auditing, such as evaluating and judging, drawing conclusions, understanding technical material and data integrity concepts, business understanding, identifying problem areas, knowledge of audit principles, and ability to manage time.
Business-related Responsibilities
Lead or participate in the continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.
Participate in the continuous improvement of the global quality system and other corporate priorities, as requested.
Establish and maintain relationships with the relevant business units, including providing audit-related advice, interpretation of Lilly global quality standards and regulations, and inspection readiness assistance.
Participate and/or support GQAAC self-assessments or regulatory inspections.
Personnel Development Responsibilities
Complete required training and qualifications as identified in your Learning Plan.
Remain current of regulatory and industry trends, including regulatory agency interpretation of requirements.
Serve as a mentor and coach for others within the GQAAC organization.
Attending training courses, conferences, or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness, as assigned.
Basic Qualifications/Requirements:
Minimum of five (5) years' experience related to the pharmaceutical industry.
Bachelor's degree - Preferred Degree in Business or Life Science-related field.
Additional Skills/Preferences:
Ability to work safely to ensure self-safety and the safety of others.
Strong working knowledge of global regulations and guidelines (e.g., DEA, FDA, EU, and industry standards (e.g., ICH, ISPE, PIC/s) for CS and GMP operations) and the ability to interpret and apply regulatory and guidelines to the pharmaceutical industry.
Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).
Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
Excellent personal skills, including motivation, self-management, commitment, and the ability to work well with others.
Excellent teamwork skills, including being open-minded and flexible to adopting new ideas.
Strong project management skills to manage projects at various stages and effectively multi-task.
Ability to maintain a flexible work schedule and adapt quickly to accommodate audit program priorities and other business-related priorities.
Working knowledge of Microsoft office 365 suite and other business programs (e.g., document management systems, quality management systems).
Additional Information:
Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 50%, sometimes on short notice.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $184,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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$115.5k-184.8k yearly Auto-Apply 3d ago
Director - Veterinary Clinical Pathologist
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenge
Eli Lilly & Company is seeking a versatile and energetic veterinary clinical pathologist to work in drug discovery and development at the Lilly Corporate Center inIndianapolis, IN. The individual selected for this position will join a talented group of pathologists reporting to the Senior Director of Pathology in the Division of Toxicology and Pathology. The individual selected should be able to work independently and collaboratively in cross-functional drug discovery and development teams within Lilly and with Lilly's external partners to provide scientific leadership in interpreting toxicity and pharmacologic effects caused by biopharmaceuticals. The successful candidate will be expected to contribute to the design, conduct, interpretation, and peer review of clinical pathology-related endpoints in animal studies supporting drug development, including pharmacology and toxicology studies. A key expectation will be to identify and bring solutions to pathology and toxicology issues affecting the discovery and development of potential biopharmaceuticals. This will be accomplished by working with a coordinated team of anatomic pathologists, toxicologists, nonclinical study managers, and other scientists. In addition, the role involves frequent interaction with external business partners, particularly assessing laboratory capabilities, validation of assays, biomarker development and/or outsourcing to meet drug development team needs, and peer review of study results. We are seeking an individual with strong communication and engagement skills to partner with a world-class organization of scientists and leverage translational and comparative medicine expertise to positively impact projects in Lilly's portfolio.
Basic Qualifications
DVM or equivalent degree and certification by the American College of Veterinary Pathologists (Clinical Pathology)
Minimum of 7 years of experience in evaluating, interpreting, and reporting GLP and non-GLP clinical pathology data from nonclinical toxicity studies
Additional Skills/Preferences
Ph.D. in a field of science
Experience in integrating clinical and anatomic pathology data from nonclinical toxicity studies
Experience in the evaluation and reporting of pathology data from animal models of human disease or other types of drug discovery studies
Clear and concise oral and written communication, particularly of pathology data
Ability to work individually or effectively in cross-functional teams on issues related to drug discovery and development
Development of scientific and regulatory perspectives on emerging issues and excellent problem-solving skills
Experience working with multiple therapeutic modalities
Training or certification in anatomic pathology
Ability to travel to Lilly business partners and regulatory agencies to conduct Lilly Toxicology and Pathology business
Familiarity with biomarker development practices, designing validation studies, and authoring reports.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$169,500 - $312,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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$169.5k-312.4k yearly Auto-Apply 8d ago
Sr. Principal Process Engineer - Small Molecule/Startup
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.
The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly's vision of serving more patients.
Success in this challenging role will require supporting the sites through startup through direct technical execution, coaching next employees, and strong collaboration - and development of the local technical and operational teams to be ready for full operation.
The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.
Key Objectives/Deliverables:
Provide Small Molecule API process engineering expertise to the Global Facility Delivery team and the Site Process Engineering team, with a strong focus on safe, right first time delivery and on-time facility start-up, through application of process engineering fundamentals
Partner with the site engineering team to provide consultation and technical problem solving related to Small Molecule unit operations, Process Safety Management, operational readiness, and C&Q support
Coach and develop local technical team capabilities to support acceleration of operational excellence and technical skills
Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions
Monitor, assess, and document equipment performance to maintain ongoing qualification of assets
Maintain the basis of safety for process equipment
Basic Requirements:
BS Engineering degree with 8-10 years experience in Small Molecule API pharmaceutical manufacturing.
Deep technical interest and understanding in manufacturing operational excellence principles.
Additional Skills/Preferences:
Excellent verbal and written communications skills.
Strong analytical and problem-solving skills.
Collaborative skills with operations, automation, and other process team members.
Ability to coach others.
Ability to influence without authority.
Ability to clarify and simplify complex issues.
Strong trust building with peers and leaders.
Willing to work off-shift hours as needed to support project milestones and training of new employees.
Other Information:
The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$114,000 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$114k-198k yearly Auto-Apply 7d ago
Containment Specialist & Capital Projects Coordinator - LRL HSE
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Description: Containment Specialist & Capital Projects Coordinator - LRL HSE
Job Level: R1 - R4
Location: Indianapolis, IN (Lilly Technology Center - North; Lilly Corporate Center)
Department: Lilly Research Labs - Health, Safety & Environment (LRL HSE)
Reports To: Sr. Director, LRL HSE
Employment Type: Full-Time
Position Summary
The Containment Specialist & Capital Projects Coordinator is a key technical resource supporting research, development, pilot plant, and laboratory operations across Indianapolis campuses. This role primarily focuses on containment engineering expertise and HSE leadership for capital projects, with supporting industrial hygiene capabilities.
The position serves as the primary technical resource for ventilated enclosure design, local exhaust ventilation optimization, containment capability evaluations, and safety-by-design integration into new construction and renovation projects. The role also provides flexible IH support across multiple business units when needed, offering exposure assessment capabilities, incident investigation support, and HSE program development.
This role will strengthen LRL HSE's ability to meet the growing demand for technical engineering and project support while building deeper organizational capability in containment engineering and capital project delivery.
Key Responsibilities:
Containment Engineering & Capital Project Support (60-70%)
Project HSE Leadership
* Serve as the HSE representative for capital projects, renovations, and infrastructure upgrades across LRL facilities.
* Integrate safety-by-design principles into early engineering deliverables, design documents, and project decision-making.
* Review engineering drawings, P&IDs, airflow diagrams, and layout plans to ensure containment and IH requirements are met.
* Conduct design risk assessments, facility siting reviews, constructability reviews, and hazard analyses (e.g., chemical, physical, ventilation risks).
* Partner with Engineering, Facilities, and scientific organizations to deliver safe, compliant, and operationally efficient capital assets.
* Support contractor safety oversight and pre-task planning when relevant to containment or exposure-related work.
Containment Engineering & Ventilation
* Lead the design, selection, installation, and performance testing of local exhaust ventilation systems including fume hoods, gloveboxes, BSCs, ventilated balance enclosures, and custom containment solutions. Work with Engineering Tech Center, Global HSE and other subject matter experts to align requirements.
* Conduct or coordinate airflow visualization studies, face velocity measurements, ASHRAE 110 evaluations, and support NSF 49 testing.
* Coordinate commissioning, performance testing, and readiness checks for new or renovated labs, equipment, and ventilation systems.
* Collaborate with senior containment engineers to analyze and improve ventilation performance, including CFD reviews, airflow modeling, and optimization of existing systems.
* Identify and close gaps in containment capability that could result in occupational exposures or operational inefficiencies.
* Drive resolution of ventilation or containment performance issues during project turnover and ongoing operations.
* Lead glovebox/isolator upgrades, enclosure retrofits, and engineering control enhancements.
* Provide HVAC and ventilation technical support during lab decommissioning, shutdowns, or reconfiguration.
* Maintain and improve LRL ventilation standards, operating procedures, and design guidelines.
* Develop specifications and performance criteria for ventilated enclosures and containment systems.
Industrial Hygiene & Operational Support (30-40%)
Containment Validation & Performance Testing
* Design and execute containment validation studies using surrogate testing methods, tracer gases, and aerosol challenge tests to verify enclosure performance.
* Conduct qualitative and quantitative exposure assessments (chemical, physical, biological) to validate effectiveness of containment systems and engineering controls.
* Perform operator protection factor (OPF) studies and leak testing for gloveboxes, isolators, and ventilated enclosures.
* Develop and implement test protocols for containment verification, including pre- and post-modification assessments.
* Analyze and interpret air sampling data, surface contamination results, and real-time monitoring to assess containment integrity.
IH Program Support & Hazard Assessment
* Perform lab and facility walkthroughs to identify exposure hazards and recommend control strategies, with emphasis on containment system effectiveness.
* Support senior IHs in evaluating new chemicals, processes, equipment, and experimental workflows through the Management of Change (MOC) process.
* Assist in incident investigations related to containment failures, exposure events, and corrective action development.
* Maintain IH compliance documentation, sampling equipment, calibration records, and containment performance databases.
* Support implementation of core HSE programs including chemical hygiene, hazard communication, and PPE programs as they relate to containment systems.
* Deliver or support HSE-related training and provide coaching to researchers, engineers, and project teams on containment validation, surrogate testing methods, and IH principles.
* Build relationships across LRL business units to provide flexible containment assessment and additional IH coverage as needed.
Basic Qualifications
* Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Environmental), Industrial Hygiene, Occupational Health, Environmental Health & Safety, or related technical field.
* 3+ years of experience in containment engineering, ventilation systems, capital project support, laboratory operations, or pharmaceutical environment.
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Preferred Qualifications
* Experience with laboratory ventilation systems, HVAC design, and containment engineering in pharmaceutical, biotech, or pilot plant settings.
* Familiarity with ASHRAE standards, NSF 49, ACGIH guidelines, OSHA, NIOSH, EPA, and applicable consensus standards.
* Experience supporting or managing capital projects from design through commissioning.
* CAD proficiency and experience reviewing engineering drawings, P&IDs, and ventilation diagrams.
* Understanding of air balancing, computational fluid dynamics (CFD), and local exhaust ventilation optimization.
* Experience with IH sampling and monitoring, exposure assessments, or industrial hygiene principles.
* Strong analytical, organizational, and project management skills.
* Excellent written and verbal communication skills.
* PE, CIH, or CSP a strong plus; willingness to pursue certification desired.
Additional Information
* Travel: Up to 10-20% business travel.
* Work Environment: Laboratory, pilot plant, mechanical rooms, rooftop and utility spaces, and office settings.
* Schedule: Standard 40-hour workweek with occasional flexibility based on project phases or testing activities.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$65.3k-169.4k yearly Auto-Apply 22h ago
Area Engineer - Lab Admin and Logistics Buildings - Lilly Medicine Foundry
Eli Lilly and Company 4.6
Lebanon, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization and Position Overview
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The Area Engineer is the site Subject Matter Expert (SME) for the Lab/Admin and Logistics Buildings (LALB) and the associated ancillary systems within the FUME (Facilities, Utilities Maintenance & Engineering) organization. During the project phase, the Area Engineer will be a key player in the cross functional project team in assisting in the design, construction, commissioning, qualification, start-up and operational readiness of all systems associated within the Lilly Medicine Foundry's LALB. During the day-to-day operation, the Area Engineer will be responsible for effectively, reliably, and cost consciously overseeing and maintaining the site's LALB and associated related equipment and systems. This includes maintaining all systems in a state of compliance, in-control, and fit for use in order to meet the needs of internal customers and/or the business. The Area Engineer will also be responsible for driving continuous improvement initiatives and managing both annual local operating and capital expenditures (CAPEX) for either requested revisions and/or new functionality or capacity. The Area Engineer will also act as the single point of contact for all residents/customers associated with the LALB.
Be the SME with a deep technical expertise in all systems under his/her responsibility, understanding their applications in pharmaceutical manufacturing and laboratory support, understanding flow charts and process parameters, and awareness of industry trends including but not limited to the following building systems:
Quality Control Laboratory Infrastructure
BSL-2 practices
Electrical Distribution
Process Gas Distribution
N2 (Nitrogen)
CO2 (Carbon Dioxide)
O2 (Oxygen)
WFI Distribution
Downflow booths
Benchtop fume hoods
Biosafety cabinets (BSC's)
Bioreactors
Benchtop chromatography systems
Safety showers / eyewash stations
Autoclaves / cabinet washers
Temperature Control Units (TCU's) and Cold Rooms
General Administrative Area Infrastructure
Electrical Distribution
Comprehensive cafeteria services
Customer / resident support services
Warehouse / Logistics Infrastructure
Cold / Freezer rooms
Sampling, milling, and dispensing suites and equipment
WFI Distribution
Fume hoods
General environmental storage conditions
Ensure the assigned processes are aligned with Industry and Lilly Standards
Support risk assessment exercises using the different tools available (e.g. FMEA)
Participate as required in teams, committees, or other groups and/or individually to achieve FUME's departmental, site and/or company goals.
Initial project asset delivery phase and future local capital investment:
Lead or participate in projects/changes for all the systems under his/her responsibility in the LALBs including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
Develop the proper documentation (URS (User Requirement Specifications), test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and remain in a state of control.
Contribute to the process resource assessment, capital plans, expense budgets, and prioritize as appropriate.
Daily Support for operations:
Monitor all systems associated with the LALBs and maintain KPI's to assure that they are operating properly and in compliance with internal and external requirements.
Act as the single point of contact for the LALBs in order to ensure compliance related activities such as deviations, change controls and CAPA's are resolved and implemented in conjunction with Operations. Quality Control, Process Engineering, Supply Chain, HSE and Quality Assurance.
Collaborate within the FUME organization in order to implement efficient and effective maintenance and reliability techniques in alignment with global engineering standards.
Apply “hands-on” problem solving skills in quickly and efficiently resolving equipment failures, troubleshooting, demonstrating RCA (Root Cause Analysis) lead investigator proficiency and guiding operations personnel in the resolution of system issues.
Provide internal customer consultation and notifications on issues that involve critical utilities and equipment associated with the LALBs.
Assure that all necessary corrective / preventive maintenance items are identified on the proper tracking systems, and ensure activities are completed by the required dates.
Provide technical assistance as necessary to FUME, HSE, Process Engineering, Supply Chain and/or Quality Control personnel.
Lead or participate in capital projects / changes for all systems under his/her responsibility in the LALBs including project management, design, resource planning, budget adherence and Qualification/Verification activities (IQ/OQ/PQ).
Support internal and external inspections and investigations (including Quality and HSE).
Maintain effective and efficient communications with appropriate site customer groups.
Basic Requirements:
Bachelor's degree in Engineering (prefer ME, MET, Chem E)
5+ years of direct engineering experience of building, utility and chemical equipment related systems and their use in a manufacturing setting, pharma preferred.
Additional Preferences:
Previous start up experience for new building and pharma equipment related systems.
Understanding of agile engineering techniques used in the management of buildings, utilities and equipment.
Previous equipment installation / commissioning / qualification experience.
Engineering experience with manufacturing / chemical plant utilities.
Engineering related project management experience.
Experience with CMMS (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems).
Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites.
Excellent interpersonal, written and verbal communication skills.
Knowledge of cGMP principles.
Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards.
Strong technical aptitude and ability to train and mentor others.
Other Information:
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$66k-171.6k yearly Auto-Apply 17d ago
HSE Permit Writer
Eli Lilly and Company 4.6
Lebanon, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Position Brand Description:
The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
Responsibilities:
Safe work permit preparation including the coordination of operations, project, and maintenance personnel.
Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc.
Develop and maintain equipment specific instructions including but not limited to lock-out, tag-out.
Develop and maintain confined space entry risk assessments.
Develop and maintain permitting equipment and supplies.
Perform safety audits and maintain an audit ready status.
Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes.
Influence adherence to project and maintenance schedules.
Support Process Engineers/Maintenance/Projects and Supervision in daily operations.
Identify and support the implementation of improvements from Operations.
Ownership of daily tasks, preventative maintenance or breakdowns.
Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs
Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards.
Understand other area processes & their operational hazards and being able to react appropriately.
Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
Basic Requirements:
High School Diploma or equivalent
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Completion of Post Offer Exam or Completion of Work Simulation if applicable.
Ability to effectively communicate (electronically, written and verbal).
Basic computer skills (desktop software) are required.
Additional Preferences:
Previous experience in facility/area start-up environments.
Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals.
Solid understanding of FDA guidelines and cGMP requirements.
Strong organizational skills and ability to handle and prioritize multiple requests.
Knowledge of lean manufacturing principles.
Flexibility - ability to troubleshoot and triage challenges.
Ability to understand technical nomenclature and language as well as work with mathematical formulas.
Manual material handling as appropriate.
Bend, reach, stretch, climb ladders, and work in tight spaces.
Stand for long period.
Additional Information:
The Safety Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc.
Ability to work flexible schedules during startup period.
Ability to work overtime as required.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$28.84 - $42.31
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Job Position Overview
The shop floor scheduler is responsible for supporting the Lebanon API Supply Chain team through managing process orders/batch records on a daily basis and providing front line support to ensure an accurate schedule. The Shop Floor Scheduler is responsible for the short term (0 - 3 months) and long term (3 - 24 months) Lebanon API scheduling through integrated tools and processes. This role is responsible for facilitating and administering documentation for manufacturing personnel on an as needed basis, providing OJT/ILT training and functioning as SME working directly with the Master Scheduler. Other responsibilities include being involved in site-wide improvement projects as appropriate.
Responsibilities
Provide day schedules to the production floor in order to maintain efficient individual plant operations resulting in target amounts of API output.
Lead/facilitate production/shop floor meetings, where applicable.
Provide weekly and monthly metric updates to monitor and track plant operational performance.
Lead and support Lebanon API OSSCE processes
Manage short- and long-term production plans.
Convert, check component availability and release process orders for shop floor.
Drive operations, QCL and QA to meet expectations of shop floor conformance.
Run MRP (Materials Requirement Planning).
Conduct local recipe audits.
Maintain S4 Hana master data and function as a power user for SAP.
Input the production plan into the master Schedule. Maintain master scheduling parameters (e.g., time fences, lead times) which become a set of planning numbers that drive MRP.
Responsible for data in SAP R/4 through creation/change of BOMs, Resources and Recipes maintenance.
Manage and review local data changes
Troubleshoot data issues in SAP where applicable.
Strict adherence to all company safety policies including the use of PPE where required.
Basic Requirements
Bachelor's degree in supply chain management or related field
3+ years of supply chain planning experience within manufacturing environment, preferable commercial or clinical FDA/ISO regulated.
Functional expertise within some and/or all following areas: SAP, Veeva, Track Wise, Microsoft Office.
Additional Skills/Preferences
Good analytical skills to deal with unexpected issues.
Extreme accuracy and attention to detail is necessary.
The ability to work independently and be able to prioritize work on multiple concurrent project initiatives is necessary.
Must be a team player, self-motivated and collaborate ideas and solutions effectively with management and colleagues.
Excellent verbal and written communication skills are essential for this position.
Knowledge of supply chain terminology and processes.
Able to manage linked activities with rapid flow of integrated information
Additional Information
The role has on-site responsibility
Position Location: US: Lebanon IN LP1
Travel Percentage (%): Minimal travel required (
Shift Information: 8 hour work days - Monday through Friday
The role operates on a standard working week. The job may also involve some non-scheduled call-in time to respond to emergencies etc. and some scheduled call-in time
Short term assignment required at domestic or international location
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$57,750 - $129,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$57.8k-129.8k yearly Auto-Apply 16d ago
Sr. Manufacturing Scientist - Small Molecule - Lebanon API
Eli Lilly and Company 4.6
Lebanon, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations.
Position Overview:
The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules. This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
Responsibilities:
Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
Develop and monitor established metrics in real-time to assess process variability and capability.
Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
Ensure that experiments are well designed with clear objectives.
Ability to analyze data and ensure appropriate documentation.
Write technical reports and documents.
Basic Requirements:
Bachelors in STEM Discipline (Chemistry preferred)
3+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred)
Additional Preferences:
Demonstrated understanding of process chemistry
Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.
Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
Familiarity with cGMP manufacturing environment and terminology.
Excellent analytical, interpersonal, written and oral communication skills.
Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
Guidance/mentoring of others through processes.
Flexibility to meet business needs.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$66k-171.6k yearly Auto-Apply 21d ago
Associate - Veterinary Technician
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Description - Veterinary Technician
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Lilly is currently hiring for a Veterinary Technician role in the Department of Nonclinical Safety Assessment, part of the Division of Veterinary Resources. In this position, the individual will be responsible for delivering healthcare to laboratory animals and offering veterinary technical support to investigators and their research teams. This role plays a vital part in supporting internal in vivo research by maintaining high standards of animal health and well-being.
Are you interested in joining a dynamic team caring for animals? Apply today to join the Lilly Team!
Responsibilities
Assists with the implementation of preventive health programs.
Under minimal direction, triages and evaluates common rodent disease conditions, provides immediate care to emergency cases, and raises problems as appropriate.
Consults with veterinarians and research personnel on treatment options.
Administers clinical treatments, collects diagnostic and environmental samples, and administers euthanasia when necessary.
Performs tasks in a manner that is consistent with departmental; institutional; local, state, and federal regulations; AAALAC accreditation standards and industry optimal methods. Reports issues of non-compliance.
Maintains animal health records. Maintains integrity of information.
Maintain adequate inventory of veterinary supplies and medications.
Provides training for animal use personnel as needed.
Required to work weekends and holidays on a rotating schedule.
Minimum Qualifications
Veterinary technician license required (RVT, LVT, CVT or equivalent)
Additional Preferences
AALAS Certification (LAT or LATG) or willingness to obtain certification highly desired.
Experience working with rodent species preferred.
Experience with standard operating procedures (SOPs), design and implementation preferred.
Excellent problem-solving abilities through utilization of good judgment and networking skills.
Highly motivated and self-directed.
Demonstrated experience and success in self-managing priorities and multi-tasking projects.
Strong problem-solving skills.
Strong interpersonal skills/team player with positive and professional approach.
Excellent written and verbal skills.
Flexible, adaptable and detail oriented.
A willingness to work in complex environments.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$41k-51k yearly est. Auto-Apply 60d+ ago
Director - Clinical Research Scientist
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Development Clinical Research Scientist will contribute to the oversight of clinical development program(s) in support of overall clinical development strategy and vision and serve as liaison and resource to various physicians and clinical trial sites, drawing on strong medical and scientific knowledge/principles, understanding compliance and regulatory requirements as well as awareness across business operations, and emerging issues.
Roles and Responsibilities of the Position:
Core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. The Clinical Research Scientist will apply scientific and clinical training and expertise to described roles.
Primary responsibility will be supporting the build, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts and other program documents.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Reporting of adverse events as mandated by corporate patient safety.
Engage in clinical development contributions to due diligence or other business development activity. Contributes, as required by program needs and in collaboration with research colleagues, to design and implement translational strategies.
Acts in parallel with the clinical lead to solicit opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. The CRS serves as a scientific resource for study teams, departments, and others as needed.
Responsible for understanding the regulatory requirements related to clinical studies and global drug development and accountable for aligning with those requirements. Become a clinical representative for key regulatory discussions.
Minimum Requirements:
An advanced health/medical/scientific degree (such as DVM, PharmD, PhD, or MSN with advanced clinical specialty).
1+ years Clinical Trials/Research experience in pharmaceutical industry, academia, research setting with a strong preference for experience within in Oncology and/or Hematology.
Additional Preferences:
Breast cancer disease area knowledge.
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
Strong analytical mind and problem-solving skills, thoughtful detail, strong organizational skills, and ability to work independently within a team.
Proven track record to bring out the best in others on a cross-functional international team. Leading by influence.
Proven track record to interact externally and internally to support a global scientific and business strategy.
Strong documentation and leadership qualities, including proficiency with MS Word, EndNote, PowerPoint and Excel.
Show one's true mettle to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
Strong communication, both written and oral.
Ability to multi-task and shift priorities rapidly to meet target dates.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $259,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$151.5k-259.6k yearly Auto-Apply 8d ago
Associate, Supply Chain Master Data Steward-Lilly Medicine Foundry
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
Role Description
The Associate, Master Data Steward plays a critical role in providing and maintaining the fundamental master data set residing in SAP and Manufacturing systems in the Lilly Medicine Foundry facility. The master data set includes Material Master, Bill of Materials, Recipes, Resources, Purchasing-Info Records and Warehousing data.
This role is responsible for maintaining the quality and integrity of the data by documenting, inputting and verifying data into SAP, the Manufacturing Execution System (MES), activities could include supporting planning, materials management and warehouse management functionality and maintaining data accuracy through inspection readiness activities, audits and Master Data changes.
This role is responsible for managing all data documentation, additions and changes, per customer or subject matter expert requirements. They will work closely with multiple teams across the site to manage data change requests, solve technical issues, and contribute to continuous improvement activities around Master Data.
The position requires knowledge of manufacturing processes of drug product in development, an understanding of the significance of accurate data management and a demonstration of an excellent eye for detail. Knowledge and familiarization with the SAP system.
Responsibilities
* Develop and maintain key and data design for Supply Chain and Materials Management Master Data (such as: Bills of Material, Receipts, purchasing info records, Purchasing and Planning/Scheduling parameters) in SAP S4 including planning, materials management, warehouse operations, potentially quality master, supplier master and associated systems.
* Work with Supply Chain Warehouse Data Lead to support the creation of warehousing operations master data, configurations and transactions.
* Creating Bills of Material, Receipts, purchasing info records, Purchasing and Planning/Scheduling parameters.
* Develop and maintain local Standard Operating Procedures (SOPs) and training materials for Supply Chain planning and Materials Management Master Data.
* Determining the impact of local and/or global changes while ensuring global data consistency and conformance to Standard Operating Procedures. These changes could include:
* SAP Master Data maintenance changes; Interfaced system changes (e.g. MES, etc.)
* Process changes driven by Technical Services / Manufacturing Sciences or Engineering teams.
* Identifying and participating in or leading process improvement initiatives.
* Leveraging appropriate tools/reports to track maintenance efforts and both data accuracy and completeness.
* Participating in annual standard costing for Business Planning and driving the review of planning parameters.
* Troubleshooting SAP execution problems, identifying root causes, and implementing solutions.
* Investigating deviations and providing impact assessments for change management.
* Serve as a key member of the SAP Implementation Project Team during the greenfield site construction/startup phase.
* Take on the temporary role during implementation as Security Steward in SAP to ensure correct security access profiles are assigned.
* Work closely with the Global Security Network on security-related topics.
* Contributing to global initiatives for Master Data Management, attending Power User forums to share best practices.
* Generate OSSCE (Operational Standards for Supply Chain Excellence) metrics and Pareto analyses.
* Maintaining a safe work environment, working safely and accountably to support all Health, Safety & Environmental Corporate and Site goals.
* Work with Tech@Lilly groups like Global Services, and Global Infrastructure to support delivery of SAP functionality and infrastructure across the site.
* Provide training and education on Master Data to Application Users and Data Owners.
Basic Requirements:
* Bachelor's degree in business, Computer Science, Supply Chain or related discipline
* Minimum of 3 years' experience in manufacturing, preferred in pharmaceutical or other regulated industries.
* Knowledge and familiarization with the SAP system such as:
* Supply chain management functionality (such as: warehouse management, materials management, production planning for process industry).
* Knowledge and work experience / master data experience in material master creation and maintenance.
Additional Preferences:
* Knowledge and familiarization with Manufacturing Execution System (MES) and its integration with SAP.
* Knowledge in Good Manufacturing Practices and Good Documentation Practices (such as FDA, ICH, GAMP5).
* Experience with business team support during and after internal quality audits or regulatory agency inspections.
* Experience with business team support of computer system validation and testing activities such as requirements definition, business scenario test documentation and acceptance testing execution.
* Business Knowledge: High performance in the delivery of their work. Critical and forward thinking to find better, simpler ways to improve user experience, takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation, and organisational skills.
* Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
* Positive Influence: Demonstrated ability to address issues as they arise and act accordingly. Trusted in the team to flowthrough on actions. Is interested in own performance and seeks feedback to improve.
* Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organisation.
* Ability to lead people: Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
* Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
* Decision Making: Demonstrated ability to be decisive and make well-informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.
* Proficiency in modern project delivery frameworks such as SAP Activate, Agile, Scrum and PMI's Body of Knowledge.
* Professional Certification in supply chain management (e.g., ASCM: CSCP, CPIM).
Other Information:
* Initial location at Indianapolis, Indiana.
* Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$58,500 - $160,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$58.5k-160.6k yearly Auto-Apply 9d ago
Clinical Research Physician - Incretin Clinical Development
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Purpose:
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource and leader for study teams, departments, and others as needed. The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
Responsibilities:
The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
General Responsibilities
Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
Actively set and meet individual professional development goals and contribute to the development of others.
Actively participate in recruitment, diversity, and retention efforts.
Collaborate proactively and productively with all alliance, business and vendor partners.
Participate in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management.
Ensures that at all times is adequately qualified and trained in the tasks required to perform Includes accountability and compliance for maintaining a current curriculum training map for self.
Model leadership behaviors.
Serve as an ambassador of both patients and the LillyBrand.
Clinical Planning
Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
Contribute to business unit and global alignment of clinical strategy and clinical plans.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support.
Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports)according to the agreed upon project timeline.
Provide oversight and input into ICDs.
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Review and approve risk profilesto ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Serve as resource to clinical operations personnel/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
Understand and actively address the scientific information needs of all investigators and personnel.
Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
Review IIT proposals and publications, as requested by Director-Medical.
Scientific Data Dissemination/Exchange
Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external healthcare professionals.
Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to guidelines above.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Support the planning of symposia, advisory board meetings, and other meetings with healthcare professionals.
Support medical information associates in preparation and review of medical letters and other medical information materials.
Prepare or review scientific information in response to customer questions or media requests
Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs.
Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support the design of customer research as medical expert.
Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel.
Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Regulatory Support Activities
Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
Provide medical expertise to regulatory scientists.
Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
Participate in advisory committees.
Participate in risk management planning along with affiliates and Global Patient Safety(GPS).
Business/ Customer Cupport
Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan.
Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers).
Actively address Development customer (payer, patient, and healthcare providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.
Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
Support business-to-business and business-to-government activities as medical expert.
Contribute actively on an ongoing basis to the strategic planning for the brand.
By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed.
Become familiar with market archetypes and potential influence on the medical interventions for the product.
Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert.
Participate in PhRMA or other local or national trade associations.
Scientific /Technical Expertise and continued development
Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer term (3-5years).
Responsible for the scientific training of the clinical study team.
Act as scientific consultant and protocol expert for clinical study team members and others in medical.
Explore and take advantage of opportunities for extramural scientific experiences.
Minimum Qualification Requirements:
Medical Doctor. US trained physicians must have achieved board eligibility or certification. Must be board-eligible or certified in one of the following: Endocrinology or Internal Medicine
Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see*******************************
Fluent in English; both written and verbal communications.
Minimum of two years clinical experience in Endocrinology
or
Internal Medicine with experience in metabolic disorders.
Minimum of five years research in metabolic disorders.
Other Information/Additional Preferences:
Location flexible but must be able to work EST standard business hours with hybrid team headquartered inIndianapolis
Demonstrated knowledge of drug development process, including clinical, regulatory, and operational aspects
Has clinical development experience in an industry setting, including clinical trial design, medical monitoring, data interpretation, and/or regulatory principles/ submissions
Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills.
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$198,000 - $356,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$198k-356.4k yearly Auto-Apply 15d ago
Sr. Director - Parenteral Technical Services Stewardship
Eli Lilly and Company 4.6
Indianapolis, IN job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Position Brand Description:
This position provides leadership for the Lilly Global Parenteral Technical Services/Manufacturing Science organization. It assures that appropriate qualified resources and systems are in place to provide technical stewardship of existing processes across all sites in the network, internal and external.
Key Objectives / Deliverables:
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountably for supporting all HSE Corporate and Site Goals
Provide leadership to global molecule stewards supporting commercial products/technical projects
Serve as initial point of contact and escalation for technical issues
Performance management and development of staff, in partnership with Executive Director - Parenteral Technical Services and Associate Vice President - Parenteral Technical Services
Assure that appropriately trained and qualified staff are in place to provide network level stewardship and execution of the Parenteral Technical Agenda
Represent the Technical Services organization at the various governance bodies to be determined by Associate Vice President - Parenteral Technical Services
Serve as facilitator of Parenteral Technical Network meetings
Develop and utilize reward and recognition initiatives for staff
Build relationships and influence manufacturing sites
Minimum Requirements:
B.S. degree or higher in a science, engineering, or technical related field
15+ years of related pharmaceutical manufacturing experience/cGMP working environment
10+ years experience in parenteral manufacturing, specifically technical services-related roles
Prior experience in technical leadership roles
Additional Preferences:
Ability to prioritize efforts
Effective written and oral communication skills
Effective interpersonal skills
Ability to maintain a safe work environment, working safely and accountably in support of all HSE Corporate and Site goals
Other Information:
8-hour days Monday through Friday
Overtime will be required, as you will need to be available off-shift and respond to operational issues as needed
Some travel will be required (
This is NOT a remote position and on-site presence is required
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly