Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities.
Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed.
The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community.
+ This is a field based sales position that will cover the **Knoxville, TN** territory. **This territory also includes Chattanooga, TN** .
+ The selected candidate must reside within the territory.
+ Overnight travel may be required about 25% of the time.
+ Travel (%) varies based on candidate's location within the geography.
**General Responsibilities:**
+ Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information
+ Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers.
+ Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account.
+ Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc.
+ Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs.
+ Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy.
+ Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs.
**Position Qualifications** **:**
**Minimum Requirements:**
+ Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience
+ Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience
+ 2+ years of oncology field sales experience
+ Valid driver's license and ability to drive a motor vehicle
+ Travel the amount of time the role requires
**Preferred Experience and Skills:**
+ Documented history of strong performance in a sales / marketing or oncology clinical role
+ Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical)
MSJR
oncosales
**Required Skills:**
Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Service, Digital Analytics, Healthcare Innovation, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Access, Market Analysis, Medical Devices, Oncology Sales, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more}
**Preferred Skills:**
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$156,900.00 - $247,000.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** .
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
01/17/2026
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R379851
$156.9k-247k yearly 9d ago
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Validation Engineer 2
Merck 4.6
Merck job in Indianapolis, IN
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your Role:
In this role you are responsible for establishing, justifying, executing, and maintaining validated cleaning processes for equipment and processes supporting existing and new clients. The position ensures that cleaning validation activities comply with applicable cGMP, FDA, and EU regulations (including 21 CFR 210 & 211, 21 CFR Part 11, EU GMPs, ICH Q7, Q8, Q9, Q10), with specific focus on control of cleaning agents and minimization of cross-batch contamination risk.
Responsibilities include but are not limited to:
Establish, justify, and validate cleaning processes for new/modified equipment and clients, ensuring full compliance with FDA and internal regulatory standards.
Author and execute IQ/OQ/PQ and CV-specific protocols, managing 3-5 annual requalification for processes, equipment, and utilities.
Serve as the site SME for cleaning-related deviations, CAPAs, and change controls, leading investigations and cleanability studies.
Author, revise, and deliver training on cleaning SOPs to Manufacturing operators to ensure qualification and documentation compliance.
Develop cleaning validation strategies, including worst-case assessments and residue limits, to control cross-batch contamination risks.
Apply statistical tools for trend analysis and continued process verification to monitor and maintain cleaning performance.
Perform technical peer reviews of protocols, reports, and risk assessments while supporting Annual Product Quality Reviews (APQRs).
Provide cleanability requirements for new system designs and demonstrate proficiency in site electronic quality management systems (eQMS).
Who You Are:
Minimum Qualifications:
PhD in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 2+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
OR
Master's Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 3+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
OR
Bachelor's Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 5+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
1+ years of experience in an aseptic pharmaceutical environment with exposure to aseptic bulk formulation, aseptic filling, and packaging processes.
Preferred Qualifications:
Prior experience in the qualification and validation of sterile facility equipment, such as sterilization technologies (Steam, Dry Heat, VHP, etc.), temperature-mapped chambers, aseptic equipment (washers, tunnels, cappers, RABS, isolators, etc.), pharmaceutical-grade utilities, process validation, and cleaning validation.
Experience in validation activities and the use of validation test equipment (e.g., Kaye Validator, Val Probe, PLC-based systems, temperature/pressure standards).
Strong verbal and written communication skills.
Self-motivated, highly organized, and conscientious, capable of working independently and in cross-functional teams in technically and mentally demanding situations.
Pay Range for this position: $67,300 - $100,900 / year
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$67.3k-100.9k yearly 10d ago
Advisor - Technical 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
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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 37d ago
Area Engineer - Lab Admin and Logistics Buildings - 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.
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 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 11d ago
Site Operational Excellence (OPEX) 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.
Position Brand Description:The Site Operational Excellence (OPEX) Lead is accountable for executing and supporting the Operational Excellence Management System for Manufacturing and Quality (M&Q). Reporting to an Operations Leader at the site, this role focuses on site-level implementation, coaching, and continuous improvement of Operational Excellence to ensure alignment with the overall strategy and governance. The Site OPEX Lead serves as the key interface between the Global OpEx team and the site, as well as the interface between the Site OPEX Team and the Site Leadership Team (SLT). The OPEX Lead is an SME in Lean, Problem Solving, Root Cause Analysis, Manufacturing Standards of Operational Excellence, and Human Performance Reliability. This role involves a balance of execution, coaching, and administrative leadership.Key Objectives / Deliverables:Business Transformation:
Lead the Site Operational Excellence Lead Team and provide Operational Excellence support for site central functions.
Own the site prioritization process, Operational Excellence education strategy, Operational Excellence roadmap, and site-wide transformational initiatives.
Participate in Site Lead Team metrics reviews, identify trends, and lead site improvement initiatives.
Assist in preparation of the Site Business and Strategic Plan; lead strategy deployment and participate in relevant SLT topics.
Influence local organizational uptake and execution of OpEx practices, tools, behaviors, and culture.
Develop, coach, and lead the local OpEx team members.
Identify, recruit, and onboard Operational Excellence talent.
Ensure strategies and projects meet safety, product quality, compliance, financial and applicable regulatory
Education and Development:
Facilitate Operational Excellence training to all levels of employees within assigned areas to support deployment and ongoing sustainability of Operational Excellence / Lean ways of working.
Coach and train teams in Lean tools and systems (for example, daily management, A3 thinking, standard work)
Coach local leaders and Operational Excellence Business Partners on program execution.
Host local Operational Excellence education and communication sessions to monitor program and resource execution, share best practices, foster collaboration, communicate and facilitate Operational Excellence learning opportunities, and apply PDCA learning cycles to improve Operational Excellence business processes.
Serve as technical leader for other Operational Excellence Business partners and build their Manufacturing operations, Lean, RCA, Problem Solving, HPR, and program management skill set.
Continuous Improvement and Project Management
Lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc.
Establish and implement project management processes and methodologies to ensure Continuous Improvement projects are delivered on time, adhere to high quality standards, and meet team expectations.
Lead the establishment of Operational Excellence systems (e.g., the Lean Production, Lean Management systems, and our digitally integrated visual management system) within assigned areas, including the components and their interactions.
Network and Knowledge Management
Facilitate shared learning and lead Operational Excellence Assessments within the site (site and globally driven).
Integrate and drive Operational Excellence culture and systems within the site.
Align with Global Operational Excellence business processes and support the delivery of OpEx objectives.
Actively engage in the broader Operational Excellence community through periodic updates, 1:1 meetings, and ad hoc discussions.
Minimum Requirements (Education, Experience, Training):
Bachelor's degree or higher in a relevant scientific or technical field.
5+ years in Manufacturing.
Prior experience in Lean, Six Sigma, or Operational Excellence.
Additional Preferences:
Demonstrated successful leadership experience and influence of cross-functional teams.
Results-oriented with excellent interpersonal and interaction skills.
Strong balance of leadership, analytical, project management, and strategic thinking skills.
Effective educator and presenter. Enthusiastic, flexible, and positive attitude Experience in Lean Manufacturing or other Productivity industry methods.
Strong communication and computer skills required.
GMP operational experience.
Other Information:
Travel (domestic and international) 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
$122,250 - $196,900
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
$122.3k-196.9k yearly Auto-Apply 60d+ ago
Director Corporate Reference Standard & Development Stability
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 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 motivated individuals who are determined to make life better for people around the world.
The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located inIndianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities.
In this role, we are seeking an experienced scientific leader that will have responsibility for ensuring the technical integrity, compliance, and business administration of a Lilly team responsible for development stability, reference standards, and critical related materials. The scientist will have influence in all phases of drug development, product registration and marketed product support by ensuring that development stability studies are properly managed and suitable reference standards are available and accurately assigned. The individual will ensure that materials and the certifying documentation are scientifically sound, properly integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The scientist will be an external leader in this technical area, set overall strategy at Lilly, and lead global Lilly scientists to ensure all related deliverables are met.
Position Responsibilities:
Technical:
Applies deep expertise in reference standards and stability science to solve complex technical challenges.
Develops and maintains a robust quality system and business processes for reference standards and stability programs.
Leverages advanced knowledge of analytical control strategies to guide material sourcing, packaging design, inventory management, equipment/facility oversight, protocol development, specification setting, and data evaluation.
Leads global technical teams to integrate and interpret complex data sets from diverse sources, enabling data-driven decision-making.
Establishes statistical techniques, defines appropriate calculations, and defines how conclusions are made to support key analytical testing and suitability decisions.
Designs processes to ensure compliance with global regulatory requirements for reference standards and stability studies.
Provides technical leadership, driving resolution of complex analytical issues.
Project Management:
Oversees planning and execution of material supply, storage, and distribution strategies aligned with material properties and intended use.
Interprets performance metrics and trends to drive timely, data-informed actions.
Builds and manages a network of internal and external partners to meet technical and capacity needs.
Owns team workload management and ensures alignment with project demand.
Ensures all activities comply with applicable regulatory and safety standards.
Customer Focus/External Focus
Influences the external scientific community to adopt Lilly best practices and align Lilly with industry best practices
Represents Lilly during external audits and in external interactions with key stakeholders
Basic Qualifications:
A Ph.D. in analytical chemistry, bioanalytical chemistry, or a related discipline with at least 10 years of experience in the biopharmaceutical sector following graduation, or alternatively, a B.S./M.S. with 15+ years of experience in the pharmaceutical industry.
Additional Skills/Preferences:
Demonstrated leadership and ability to influence across internal and external teams.
Deep expertise in analytical sciences, including measurement techniques, specifications, and statistical data analysis.
Strong background in reference standards and stability science across diverse molecular modalities.
Solid understanding of chemical synthesis, purification, formulation, packaging, and inventory management.
Proficient in statistical tools and computerized systems such as LIMS and inventory management platforms.
Strong communication and interpersonal skills, with a consistent record of collaboration.
High attention to detail and ability to adapt to shifting priorities while managing ambiguity.
Strong compliance mindset with thorough knowledge of regulatory and safety requirements.
Additional Information:
Travel: 5 to 10%
Potential exposure to chemicals, allergens, extreme temperatures, and loud noises.
Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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
$148,500 - $257,400
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
$148.5k-257.4k yearly Auto-Apply 60d+ ago
Scientific Director - Sustainable Peptide Process Chemistry - SMDD
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. 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:
Help shape the future of sustainable peptide development and bring life-changing incretin therapies to patients around the world! An exciting opportunity is available for a highly skilled and experienced scientist with expertise in peptide process chemistry to join the Synthetic Molecule Design and Development (SMDD) division at Eli Lilly and Company. You will be part of a dynamic, cross-functional department focused on sustainable synthetic peptide development and commercialization. In this role, you'll lead a variety of peptide commercialization projects, collaborate with global partners, and help advance next-generation, sustainable approaches to peptide manufacturing. This includes process development for Mounjaro and the commercial process development of multiple incretin peptide candidates progressing toward market launch.
Lilly is a global leader in incretin-based therapies, with a rapidly expanding portfolio that is transforming the treatment of diabetes, obesity, and related metabolic diseases. By joining this team, you will play a key role in shaping the future of this industry-leading pipeline and enabling access to breakthrough peptide medicines worldwide. We're looking for an innovative and energetic peptide chemist with a strong leadership background and deep industry knowledge. You'll work closely with a growing team of chemists, analysts, and engineers to design efficient synthetic routes and optimize commercial processes - helping to deliver the next generation of peptide therapies to patients around the world.
Responsibilities:
Lead a team of peptide chemists in designing and developing sustainable synthetic peptide processes.
Provide oversight for multi-kg scale peptide process development at contract manufacturing organizations (CMOs) and lead internal development activities.
Educate and mentor CMOs on best practices for greener peptide development and manufacturing.
Present research findings at internal forums and external conferences; publish in high-quality, peer-reviewed journals.
Communicate both the technical and business implications of research outcomes clearly and effectively.
Apply expertise in Tag-Assisted Liquid-Phase Peptide Chemistry to enable scalable and efficient peptide synthesis.
Top Candidates Will:
Demonstrate excellence in multiple modes of peptide synthesis, including hybrid SPPS/LPPS chemistry.
Have experience leading teams of scientists in peptide route development.
Enable the design, development, and implementation of sustainable, innovative processes for complex peptide synthesis, with a focus on PFAS-free conditions.
Implement green chemistry and engineering solutions to improve the environmental footprint of peptide manufacturing and reduce Process Mass Intensity (PMI).
Possess familiarity with chromatography, mass spectrometry, optical spectroscopy, and peptide automation.
Exhibit strong technical problem-solving ability and an intrinsic motivation to succeed in team environments.
Have a track record of innovative scientific research, demonstrated by publications in high-quality, peer-reviewed journals and presentations at external conferences.
Basic Qualifications:
Ph.D. in Chemistry or related field with 7+ years of pharmaceutical industry experience, or
B.S./M.S. in Chemistry with 12+ years of relevant experience in industry or academia.
Additional Preferences:
Strong interpersonal skills and a sustained track record of collaboration.
Ability to learn and apply new technical knowledge to meet evolving project needs.
Demonstrated flexibility, prioritization skills, and the ability to work effectively in dynamic environments.
Proven leadership capabilities, especially in cross-functional or global team settings.
Ability to balance multiple priorities and navigate ambiguity effectively.
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with a lab and office environment. Travel: 0-10%
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 a laboratory and office environment.
The
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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
$148,500 - $257,400
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
$148.5k-257.4k yearly Auto-Apply 60d+ 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 in Science or Engineering
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.
#WeAreLilly
$115.5k-184.8k yearly Auto-Apply 60d+ 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
Quality Assurance Associate - Drug Product External Manufacturing
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 Overview
Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.
The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.
Key Objectives/Deliverables:
Lead/ provide support to launch new products/ packages/ CMs
Participate on Joint Process Teams
Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.
Levelling, reviewing, and approving of event investigations and changes.
Work with Lilly support groups and SME's to resolve product related issues
Participate in the creation and revision of standard operating procedures
Participate on Six Sigma Projects to help improve productivity
Provide support on site or remotely during inspections
Author and track compliance to the CM Quality Agreements and CM Quality Plans
Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess/monitor performance.
Routinely have face-to-face communications with CMs
Track and monitor Quality metrics for trends at the CM
Support Qualifications/ Validation document creation and reviews
Provide and coordinate designated sections for Annual Reports and Annual Product Reviews
Execute SOP assessments of CMs and track completion of outstanding issues
Support CMs effort to maintain and improve their quality systems
Provide technical leadership and project management oversight to drive improvements to CM quality systems
Build and maintain regular communication with External Manufacturers and awareness of issues/progress including reporting back to DPEM Management. Also responds to request of information and data.
Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight
Network with external partners and resources to share and learn best practices and trends within the industry
Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
Basic Qualifications:
Bachelor´s Degree in Pharmacy, Chemistry, Biological Science or other relevant field
5+ year of parenteral product manufacturing and quality experience
Additional Skills/ Preferences:
Knowledge of Pharmaceutical Manufacturing Operations
Strong written and communication skills, especially attention to detail in written procedures and protocol development.
High learning agility.
Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
Ability to organize, prioritize, multi-task and influence others.
Strong decision making and problem-solving skills.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Proven ability to work independently or as part of a Team to problem solve
Regulatory related experience.
Established technical, quality, and internal networks.
Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
Preferable minimum of 5 years of experience supporting manufacturing
Additional Information:
Shift is days, but off-hours may be necessary to support operations
Travel up to 30%
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
$56k-69k yearly est. Auto-Apply 5d ago
HSE Permit Writer - 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.
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.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), operational 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.
Position Overview:
The Lilly Medicine Foundry Health Safety and Environment (HSE) Permit Writer actively supports start-up activities to bring manufacturing equipment into service. The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production area. A successful candidate will interface with the Process Team and Project Team to manage equipment availability.
This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. In the pre-startup phase, the HSE Permitter will contribute heavily to Operational Readiness preparations for the new facility, such as creation of trainings, procedures, and workflows to support future Foundry needs and operating plans.
Responsibilities:
An HSE Permitter ensures that all necessary permits are accurately prepared and issued for various work activities. They play a crucial role in maintaining compliance with safety regulations by conducting thorough risk assessments, developing safety plans, and auditing live work permits. To excel in this role, they must exhibit meticulous attention to detail, effective problem-solving abilities, excellent communication skills, a solid understanding of technical hazards, and strong organizational skills. In line with the job outlined above, the following are typically the key tasks that would be expected of the role:
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 equipment specific lock-out, tag-out, try procedures.
Develop 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.
Lead departmental improvement projects related to safety, LOTO practices, 5S, equipment maintainability and accessibility, ergonomic improvements, etc.
Support Process Engineers/Maintenance/Projects and Supervision in daily operations.
Identify and support the implementation of improvements from Operations.
Own the issuance of non-routine work instructions with input from Process Chemists/Process Engineers.
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:
HS Diploma/GED
5+ years of directly applicable bulk API (active pharmaceutical ingredient) manufacturing experience, GMP and/or chemical processing strongly preferred.
Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals.
Experience coordinating maintenance, LOTO, and/or piping change activities in a GMP production 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
Additional Skills/Preferences:
Previous experience in facility or area start-up environments.
A solid understanding of FDA guidelines and cGMP requirements.
Strong organizational skills with the ability to handle and prioritize multiple requests.
Knowledge of lean manufacturing principles.
Flexibility to troubleshoot and triage challenges effectively.
The ability to understand technical nomenclature and language, as well as work with mathematical formulas.
Ability to effectively communicate (electronically, written, and verbally).
Basic computer skills (desktop software) are required.
Additional Information:
Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location inIndianapolis, IN during pre-startup phase
Travel Percentage: 5%
The HSE 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. Flexibility in work schedules and the ability to work overtime as needed are essential.
Position requires on-site presence on a M-F schedule, with flexibility to support activities in a 24-hour manufacturing environment during shutdowns, weekends, etc.
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 - $46.54
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
$79k-103k yearly est. Auto-Apply 1d ago
Clinical Research Scientist - Breast Cancer Franchise
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 Overview:
The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
Primary Responsibilities
Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
Demonstrate compliance with procedures and be accountable for compliance of team members.
Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
Collaborate with Global Patient Safety on risk management planning.
Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
Partake in data analysis, scientific dissemination, and preparation of final study reports.
Analyze and contextualize clinical data to support decision-making and portfolio strategy.
Contribute to strategy and innovation through cross-functional working groups.
Support planning and execution of symposia, advisory boards, and other external engagements.
Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Scientific & Technical Expertise and Development
Stay current with medical literature and scientific developments in breast oncology.
Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
Leadership & Professional Development
Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
Basic qualifications:
PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
3+ years of clinical research scientist experience/clinical trial experience
Leadership experience
Additional Information/Preferences:
Direct Line Leadership experience Breast cancer disease state knowledge/experience
An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
Strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
Fluent in English, verbal and written communication
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
$177,000 - $308,000
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
$177k-308k yearly Auto-Apply 31d ago
Chemist - Industrial Hygiene Lab
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:
The Lilly Industrial Hygiene (IH) Lab provides trace analytical services for the company's global Industrial Hygiene (IH) community. A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Lab staff work closely with site/location Industrial Hygienists to provide routine analysis of samples taken in the development and manufacturing space in support of employee exposure assessment, and they coordinate all 3rd party analytical needs including external data review and release. As well, lab staff provide creative technical solutions and project support for emerging needs as identified by the global IH community. This position reports through the Global Health, Safety, and Environment organization.
Responsibilities:
A primary mission of the IH Lab is to develop and validate monitoring methods for active pharmaceutical ingredients (APIs) coming from the clinical development pipeline. Monitoring methods typically include air sampling methods for personnel exposure characterization and swab methods for cleaning effectiveness after spills and decommissioning but may also include air and water monitoring methods and sample analysis for environmental evaluations. Key responsibilities of this position include:
Partnering with internal customers and external lab vendors to efficiently meet business needs.
Developing and validating air and surface monitoring methods, including sampling media. This may involve internal/external research and troubleshooting until an acceptable recovery is achieved.
Conduct laboratory analysis of active pharmaceutical ingredient (API) samples collected globally.
Coordinating sample analysis with third party laboratories and conducting a review of results before releasing to internal customers.
Calculating, documenting, and reporting study results via established laboratory programs such as electronic notebooks and laboratory software application.
Routinely monitoring the clinical development pipeline, connecting with site Industrial Hygienists to prioritize method development needs, and initiating requests when an occupational guideline limit is needed.
Peer reviewing laboratory data to confirm it is accurate and in compliance with procedures, assuring data is stored as required for archival, and supporting laboratory data quality assessment.
Researching and supporting the solution of key technical, operational, or business problems, as needed.
Organizing and/or conducting laboratory inspections and supporting the resolution of observations or areas for improvements.
Representing Lilly in the AIHA Pharma Round Robin and participating in external scientific forums, as appropriate.
Maintaining awareness of analytical sciences, pharmaceutical industry trends and industrial hygiene issues to drive continuous improvement in laboratory services.
Basic Requirements:
B.S. with > 5 years of relevant experience or M.S. with >3 years of relevant experience in chemistry, biochemistry, or closely related field of study
Mass spectrometry, liquid, and gas chromatography analytical method development experience.
Additional Skills/Preferences:
Proteomics experience strongly preferred.
Experience in ISO 17025 accredited laboratory.
Industrial Hygiene Chemist Certification.
Experience in GMP lab operations and Lean.
Coursework or experience in industrial hygiene or environmental sampling.
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 29d ago
Sr. Principal Process Engineer - Peptide Synthesis/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 Peptide 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 Peptide API 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 Peptide Synthesis or Purification 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 60d+ ago
Associate - Clinical Trials - Clinical Data
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 challenges.
**Please note, this is a hybrid position 3 days onsite/2 days remote**
Purpose:
This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs.
Primary Responsibilities:
Portfolio Strategy, Planning and Delivery
Define Lilly business requirements for the study/program for vendors to deliver
Ensure that data management timeline and results are delivered to scope, cost, and time objectives
Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery
Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)
Define and approve data quality and submission outputs and results
Project Management
Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
Specifies the data collection tools and technology platforms for the trial/program
Drive standards decisions, implementation and compliance for the study/program
Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
Facilitate/assimilate integration of disparate data sources into datasets for decision making
Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
Communication
Act as primary communication point for all data management activities related to a clinical study.
Report out status of data management milestones and data quality.
Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions.
Partner with cross-functional team members to ensure trial success through robust oversight/review.
Process Improvement
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Represent data sciences' processes in multi-functional initiatives.
Actively engage in shared learning across the Data and Analytics organization.
Work with partners to increase vendor/partner efficiencies
Minimum Qualification Requirements:
Master's degree in a scientific discipline such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Science
OR
Bachelor's degree discipline above, plus 3+ years of experience in clinical trials, data management, or related areas (e.g., statistics, data analytics, information technology, health outcomes).
Other Information/Additional Preferences:
Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities
Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results
Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles
Demonstrated ability to lead development of creative data solutions to address clinical development challenges
Passionate about improving technological solutions using new technologies
Society of Clinical Data Management certification
Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, ‘R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS.
Experience with the following:
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge in the field of research
Knowledge of medical terminology
Domestic and International travel may be required
Ability to balance multiple activities, prioritize and manage ambiguity
Demonstrated exemplary teamwork/interpersonal skills
Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
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 - $165,000
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
$65.3k-165k yearly Auto-Apply 1d ago
Manager, Catalyze360 IT Contracts & Business Operations
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
Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.
Job Summary
The Manager of IT Contracts & Business Operations is responsible for negotiating fee-for-service IT contracts across the Lilly Catalyze360 organization. This role requires a proactive, self-driven individual with deep expertise in AI technologies and IT infrastructure and services who can navigate technical complexity while securing favorable commercial terms. The ideal candidate stays current on emerging AI/ML and other IT trends, understands their practical business applications, and can translate that knowledge into well-structured agreements that protect Lilly's interests while enabling innovation. This individual will provide contract matter expertise for IT engagements and collaborate with legal, finance, and technical stakeholders to structure agreements that balance business needs, risk mitigation, and cost optimization. The role has potential to expand into managing Business Operations IT pilots and systems implementations as well.
Key Responsibilities
* Negotiate complex contracts for a variety of Catalyze360 IT needs, including IT professional services, software license, software development, service level, SaaS/PaaS/IaaS, and AI/ML agreements as well as associated change orders
* Serve as the primary interface between Business Operations and IT/business stakeholders, translating technical requirements into contractual terms and managing vendor relationships to ensure alignment with business objectives
* Collaborate cross functionally with IT/business, legal, finance, and other stakeholders to structure IT agreements that balance business needs, risk mitigation, and cost optimization
* Identify and mitigate business risks throughout the contracting process, including protecting sensitive confidential information and privacy
* Manage multiple concurrent IT contract negotiations while monitoring performance and vendor compliance
* Potential to oversee implementation, configuration, and ongoing management of Contract Lifecycle Management (CLM) and other systems to optimize contracting processes and ensure compliance
* Potential to structure and oversee Business Operations pilot programs and promote adoption of successful pilot solutions
Minimum Requirements
* Education: Bachelor's degree from an accredited college or university
* Experience: 3+ years of experience with a variety of IT contract negotiations (including IT professional services, software license, software development, service level, and SaaS agreements) in the biotechnology/ pharmaceutical or other regulated industry
* Work Authorization: Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
Additional Skills/Preferences
* Experience
* Demonstrated experience negotiating contracts for AI/ML applications across drug discovery and development
* Prior experience designing and coordinating pilot programs, proof-of-concept initiatives, or technology evaluations
* Experience with Contract Lifecycle Management (CLM) system implementation and optimization
* Skills
* Strong understanding of and fluency with IT architecture, cloud infrastructure, software development lifecycle, and enterprise technology solutions
* Advanced expertise in Intellectual Property frameworks for AI/ML efforts
* Deep understanding of IT security requirements, compliance frameworks including privacy regulations, and data governance in regulated industries
* Ability to work through competing priorities with speed and agility in a highly collaborative environment with diverse stakeholders
* Excellent communication skills with ability to engage diverse stakeholders including technical, legal, and finance team members
* Strong analytical and problem-solving capabilities with strategic thinking and an entrepreneurial mindset
Additional Information
* Travel up to 10% US as needed for stakeholder engagement and vendor meetings.
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
$69,000 - $165,000
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.
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$69k-165k yearly Auto-Apply 1d ago
Engineer - Automation Engineering - Hardware, Instrumentation and Controls - 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.
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 Engineer - Automation Engineering will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Process Automation is core to delivering a right first time facility start up and continued support of ongoing manufacturing operations into the future.
The Engineer is also responsible for the productivity and mentorship of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Senior Principal Engineer as a key technical expert with partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering 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.
Key Objectives/Deliverables:
• Technical Leadership
• Mentor process control team, including design, controls philosophy, implementation and commissioning
• Process control work implementation and coordination
• Develop and implement the Automation Engineering Project Plan.
Operational Excellence
• Technically lead and oversee the work of Site Area leads and System Integrators and review Functional Requirements, Design Specifications, automation hardware, application software, Test Specifications.
• Lead/Participate in design reviews and Site system hardware reviews, attend equipment and software FATs
• Lead a team of automation engineers supporting commissioning
• Provide periodic status updates to Project Management
• Devise functional requirements and process control strategies for control systems in collaboration with Automation System Administrators to ensure all required hardware, instrumentation and controls are accounted for
• Perform Automation Engineering activities including design, tuning and troubleshooting of control loops, devices and hardware
• Implement and support electronic systems (such as plant historians) used to capture process automation related production data
• Maintain the validated state of the site control system hardware in line with Lilly quality standards including the development and execution of validation strategies and associated documentation
• Automation support for capital projects including new product introductions
• Promote the use of automation to improve productivity, operational efficiency and compliance
• Develop a ‘network' of corporate contacts and leveraging corporate expertise when needed
• Perform Site support that will include shift rotation to provide continuous support of day to day activities
Organizational Capability
• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
• Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
• Possess a keen technical curiosity and has demonstrated strong problem-solving skills and a desire for continuous improvement
• Demonstrated ability to influence peers and business partners
• Good written and verbal communication skills for both technical and non-technical audiences
• Knowledge of GMP, regulatory requirements, computer system validation
Basic Requirements:
• Minimum B.S. in Engineering and experience in Automation Engineering, preferably in major pharmaceutical manufacturing.
• A minimum of 2+ years working experience in Biopharma engineering, operations, or manufacturing.
Additional Preferences:
• Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, BMS controller and hardware, valves, motors, control panels, and Warehouse and Robotics systems (DeltaV, Rockwell, Johson Controls, Fanuc, Rosemount, Fisher etc).
• Experience in facilitating and driving decision-making at an organizational level.
• For Internal Lilly employees - LRL/Product Research Development experience preferred
Other Information:
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicines 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
$64,500 - $167,200
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
$64.5k-167.2k yearly Auto-Apply 5d 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.
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$66k-171.6k yearly Auto-Apply 8d ago
Senior Research Director, Analytical Chemistry - Synthetic Molecule Design and 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.
The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By fostering a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.
Position Summary:
The Senior Research Director, Analytical Chemistry, will be responsible for the technical leadership and execution of analytical efforts for the commercial development of drug substance and/or drug product processes. Our team is seeking experienced, innovative, and motivated scientists to apply their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory submissions, and new product commercialization. This technical-track role offers the opportunity to lead the analytical effort within a multidisciplinary project team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical development.
Responsibilities:
Drive implementation of technical solutions and analytical strategies to enable drug substance process or drug product formulation development.
Collaborate with project development teams, regulatory scientists, and manufacturing partners to deliver robust control strategies for drug substances, drug products, and/or drug product intermediates (e.g., spray-dried dispersions).
Apply prior experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets.
Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed, and fit for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation).
Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
Welcome varied perspectives to create new solutions.
Actively engage in the external environment; recognize and apply external innovation across the Lilly synthetic portfolio.
Basic Requirements:
Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field
8+ years' experience in a pharmaceutical industry setting with specific focus on small molecules, synthetic peptides, or oligonucleotides.
Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization. Proven skills developing, validating, and transferring analytical methods, authoring regulatory documentation, and overseeing CMO/CRO activities.
Must possess strong communication (oral, written), organizational, and leadership skills.
Additional Preferences:
Experience with product commercialization, including technical transfer of analytical methods into manufacturing operations.
Demonstrated ability to drive and accept change.
Good interpersonal skills and a sustained tendency for collaboration.
Demonstrated success in persuasion, influence, and negotiation.
Additional Information:
Travel: 0 to 10%
Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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
$144,000 - $250,800
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