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Sr. Principal Scientist - TS/MS Device & Packaging
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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.
Join us at Eli Lilly in a dynamic role where you'll be a pivotal force in our Device and Packaging Manufacturing division, supporting our mission to deliver life-saving medications to patients worldwide. As a Specialist in Technical Services/Manufacturing Sciences (TS/MS), you will provide technical oversight and will work to deliver successful approaches for new and existing medicines introduced on lines, support technical transfer, and optimize existing control and capacity to maintain the reliable supply for products across the site.
Key Objectives and Deliverables:
Technical Subject Matter Expert (SME) Oversight:
Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support by being flexible, proactive and involved.
Liaise with regulatory function to align on strategies for new products, packaging, platform changes and planning for consolidated technical change agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance process.
Engage externally to ensure the organization stays current in the evolving risk management, state-of-the-art technology, regulatory and compliance environment. Leverage these to improve strategies and applications for developing and controlling design transfer and manufacturing processes.
Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes.
Independently identify the key engineering questions/issues and develops solutions to advance business objectives.
Innovation and Problem-Solving:
Provide technical and effective process support services for production issue resolution and investigation with proficient data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance.
Identify and drive improvement opportunities. Implement the organization's technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.
Support complex investigation of key issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence.
Regulatory Compliance:
Ensure adherence to current regulatory requirements, including cGMP standards, ISO 14971, ISO 11608, OSHA regulations, and environmental sustainability goals.
Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
Identify weaknesses and opportunities in control strategy and pursue improvements and resolution.
Establish guidance and standards for critical aspects of the operational and equipment control strategy supporting device and packaging platforms.
Process Optimization:
Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, automation, and product to improve. product/process robustness, reduce variability, and provide improvement in control strategies.
Perform process monitoring of critical parameters and react to signals/trends to drive continuous improvement, process capability and prevention of issues.
Cross Functional Collaboration:
Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share best practices, technical principles and meet manufacturing goals.
Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness.
Mentorship:
Mentor and provide coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. This may include coaching on first principles, change or deviation management and processing issue resolution.
Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive.
Willingness to openly share, to speak up and ensure others understand the risks when making business choices and decisions.
Safety and Quality Culture:
Lead by example in building and driving a culture of safety first and quality always within the organization.
Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Minimum Qualifications:
Bachelor's degree in Science, Engineering, or related field.
5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry.
Strong understanding of cGMPs and pharmaceutical or regulated industry manufacturing.
Ability to lead complex technical projects and make informed decisions.
Additional preferences:
Prior experience in packaging and/or device assembling operations.
Familiarity with Commercialization process and Process Control requirements.
Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.
Demonstrated, strong analytical and problem-solving abilities.
Project management experience and basic statistical skills.
Working knowledge of equipment and facility qualification processes.
Safety equipment (PPE) and precautions required in the manufacturing plant environment.
Variable travel may be required to support business needs, 0-50%.
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
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ASCP Certified Lab Scientist - Sign On Bonus Eligible!
K.A. Recruiting
Senior principal scientist job in Waterloo, IN
Certified Lab Scientist
Are you a detail-oriented lab professional ready to take the next step in your career? A trusted and well-respected healthcare facility in Waterloo, Indiana is looking for a Certified Lab Scientist to join its clinical laboratory team. This is a full-time, on-site opportunity with a sign-on bonus available for eligible candidates.
About the Role
As a Certified Lab Scientist, you'll play a vital role in the delivery of high-quality diagnostic testing. You'll ensure that patient results are accurate, timely, and in compliance with laboratory standards. Beyond testing, you'll contribute to equipment maintenance, staff training, and ongoing quality improvement initiatives.
Key Responsibilities:
Perform a wide range of clinical laboratory tests with accuracy and efficiency
Maintain, calibrate, and troubleshoot laboratory instruments
Assist with validation and implementation of new tests or equipment
Provide training and guidance to fellow lab team members
Support inspection readiness and maintain regulatory compliance
Participate in lab-based committees and continuous improvement projects
Why This Role Stands Out
Sign-on bonus available for eligible hires
Be part of a collaborative and well-equipped lab team
Work in a supportive, patient-centered environment
Opportunities for professional growth and leadership involvement
Contribute to a culture of excellence and continuous improvement in care
$63k-93k yearly est. 16d ago
Research Scientist
Dekalb Health 4.4
Senior principal scientist job in Fort Wayne, IN
The Health Services and Informatics Research Scientist is a key member of the Parkview Research Center (PRC), focusing on Health Services and Informatics Research. This role is responsible for developing the scientific foundation and methodology for research proposals-both internal and external-and preparing associated protocols for Institutional Review Board (IRB) submission. The scientist collaborates closely with other members of the health services research team to execute study protocols, apply rigorous scientific methods, and lead data analysis efforts.
Due to the unique and applied nature of the Health Services and Informatics Research Lab at Parkview Health, this role plays a vital part in identifying and addressing real-world problems within the health system. The scientist partners with clinical colleagues to design and implement projects aimed at improving healthcare processes and patient outcomes. Responsibilities include the development of robust program evaluations, interdisciplinary research protocols, and competitive grant proposals.
This position is also charged with building a sustainable research platform by securing external funding. The ideal candidate is capable of working independently across all phases of research-including study design, decision-making, data analysis, and problem solving. They will also lead the development of peer-reviewed manuscripts and other forms of dissemination, such as conference presentations. The scientist manages and monitors work plans to ensure timely progress toward project goals and deliverables.
The role requires adaptability to align with the working styles of both internal team members and external collaborators. The successful candidate will cultivate strong professional relationships, contribute to a collegial and inclusive team environment, and actively support the growth and success of peers and projects across PRC.
Education
PhD in a field applicable to health services research (e.g., Health Informatics, Computer Science, Psychology, Human-Computer Interaction Design, Social Computing, etc.).
Experience
* Minimum of 2 years of experience in field research and data analysis required.
* Post-doctoral fellowship or prior professional experience in a healthcare setting preferred.
Other Qualifications
* Proficient in advanced research methodologies, including statistical techniques and study design across epidemiology, behavioral, clinical, and translational research.
* Ability to independently execute research activities aligned with organizational goals.
* Strong written and verbal communication skills.
* Proven track record in producing high-quality research outputs, such as grant proposals, abstracts, manuscripts, and conference materials.
* Expertise in methods related to human-computer interaction design and applied health informatics is highly valued.
$58k-70k yearly est. 46d ago
Advisor Research Scientist (Purification) - ADN RAMP Team
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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 (Active Pharmaceutical Ingredient) 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 Responsibilities:
Lead the successful transfer of new molecules into production at Lilly Sites
Leverage internal and external expertise to improve existing production processes focused on purification of peptides
Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production
Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processes
Develop strong working relationships with both R&D and plant sites to ensure success
Serves as a member of multidisciplinary product development teams responsible for the commercial scale development of new processes. He/she typically directs the laboratory activities and development of one or more junior staff members
Participate in the Science Lead Team- part of scientific governance/oversight for Lilly sites.
Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects. Be the technical steward on all products they are accountable for.
Define and lead TS/MS technical projects (experimental, modelling and/or production data analysis) to improve process control, yield, purity and/or productivity.
The Research Scientist/Senior Research Scientist should also have a proven track record in the following areas.
Demonstrated ability to commercialize and solve manufacturing problems.
Hands on experience supporting production at different scales from both a commercialization and supply perspective.
Proven track record of working with diverse groups across the value chain and in multiple locations
Understanding the interaction of bulk drug substance and drug product formulation
interaction of equipment set(s) with process (drug substance and drug product)
Significant experience with registration, including authoring of technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.
Basic Requirements:
BSc/MSc/PhD in Chemistry/Biochemistry or related science discipline.
BSc requires 10+ years of industrial experience. MSc/PhD requires 5+ years of industrial experience.
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
Research Scientist
Parkview Health 4.4
Senior principal scientist job in Fort Wayne, IN
The Health Services and Informatics Research Scientist is a key member of the Parkview Research Center (PRC), focusing on Health Services and Informatics Research. This role is responsible for developing the scientific foundation and methodology for research proposals#both internal and external#and preparing associated protocols for Institutional Review Board (IRB) submission.
The scientist collaborates closely with other members of the health services research team to execute study protocols, apply rigorous scientific methods, and lead data analysis efforts.
Due to the unique and applied nature of the Health Services and Informatics Research Lab at Parkview Health, this role plays a vital part in identifying and addressing real-world problems within the health system.
The scientist partners with clinical colleagues to design and implement projects aimed at improving healthcare processes and patient outcomes.
Responsibilities include the development of robust program evaluations, interdisciplinary research protocols, and competitive grant proposals.
This position is also charged with building a sustainable research platform by securing external funding.
The ideal candidate is capable of working independently across all phases of research#including study design, decision-making, data analysis, and problem solving.
They will also lead the development of peer-reviewed manuscripts and other forms of dissemination, such as conference presentations.
The scientist manages and monitors work plans to ensure timely progress toward project goals and deliverables.
The role requires adaptability to align with the working styles of both internal team members and external collaborators.
The successful candidate will cultivate strong professional relationships, contribute to a collegial and inclusive team environment, and actively support the growth and success of peers and projects across PRC.
Education PhD in a field applicable to health services research (e.
g.
, Health Informatics, Computer Science, Psychology, Human-Computer Interaction Design, Social Computing, etc.
).
Experience Minimum of 2 years of experience in field research and data analysis required.
Post-doctoral fellowship or prior professional experience in a healthcare setting preferred.
Other Qualifications Proficient in advanced research methodologies, including statistical techniques and study design across epidemiology, behavioral, clinical, and translational research.
Ability to independently execute research activities aligned with organizational goals.
Strong written and verbal communication skills.
Proven track record in producing high-quality research outputs, such as grant proposals, abstracts, manuscripts, and conference materials.
Expertise in methods related to human-computer interaction design and applied health informatics is highly valued.
$58k-70k yearly est. 45d ago
Certified Laboratory Scientist - Night Shift (Microbiology)
K.A. Recruiting
Senior principal scientist job in Monroeville, IN
Join a respected healthcare organization in Northeast Indiana, where your expertise in clinical microbiology and diagnostic testing will directly impact patient outcomes. This full-time night shift opportunity is ideal for a certified Laboratory Scientist seeking to work in a forward-thinking, quality-driven lab environment.
About the Role
As a Certified Lab Scientist, you'll play a critical role in microbiological testing and lab operations, ensuring accurate and timely diagnostics that support patient care and clinical decision-making.
Key Responsibilities:
Perform a range of clinical laboratory tests and microbiology procedures in accordance with lab standards
Maintain and troubleshoot lab instruments and support the development of new tests
Train and mentor other laboratory professionals
Participate in internal projects and performance improvement initiatives
Maintain the lab in a state of continuous readiness for inspections and accreditations
Use sound judgment in result interpretation, ensuring high-quality patient outcomes
Serve as a technical and procedural resource for other team members
Why Apply?
Night Shift Stability - Enjoy consistent overnight scheduling
Microbiology Focus - Specialize in a vital, high-skill area of clinical testing
Advanced Technology - Utilize modern instrumentation and lab automation
Growth Environment - Be part of an organization that values education, leadership, and innovation
Competitive Benefits - Receive a strong compensation and benefits package, with ongoing training opportunities
$63k-93k yearly est. 16d ago
Principal Scientist - TS/MS API External Manufacturing (Peptides/Small Molecule)
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Senior or PrincipalScientist will join the Technical Services/Manufacturing Sciences (TS/MS) team who work within a dynamic external manufacturing environment to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/PrincipalScientist acts as an SME responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners, process team members and site management.
The candidate will be responsible for technical transfer, process stewardship, process monitoring and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Key Objectives/Deliverables:
Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
Leads resolution of technical issues including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
Build and maintain relationships with development partners and central technical organizations.
Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
Maintaining peptide/oligonucleotide processes in a state of compliance with US and global regulations
Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
Operate with ‘Team Lilly' in mind - including coaching and mentoring of peers and other scientists.
Basic Requirements:
Bachelors in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred)
3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Preferences:
Knowledge and experience with Regulatory requirements
Enthusiasm for changes, team spirit and flexibility
Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
Proficiency in delivering complex tasks and/or tasks that are cross-functional
Demonstrated Project Management skills and ability to coordinate complex projects
Additional Information
Some travel (
Some off-shift work (night/weekend) may be required to support 24/7 operations
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).
This position is located onsite in Indianapolis, IN and is not approved for remote work.
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 60d+ ago
Certified Lab Scientist - Microbiology (Nights)
K.A. Recruiting
Senior principal scientist job in Ossian, IN
Step into a dynamic, high-volume hospital laboratory that plays a critical role in the diagnosis and treatment of infectious diseases. We're seeking a Certified Lab Scientist to join the Microbiology team on the night shift at a respected medical facility in Ossian, IN.
Location: On-site in Ossian, IN
Schedule: Full-Time | Night Shift (with differentials!)
Compensation: Competitive pay + Sign-On Bonus (based on experience)
What You'll Do:
Perform high-complexity testing in microbiology, including cultures, gram stains, molecular and serologic testing
Process and analyze a wide range of clinical specimens with precision and efficiency
Maintain, troubleshoot, and calibrate instruments and lab equipment
Follow all regulatory, safety, and quality control protocols
Collaborate with pathologists, infection control, and clinical teams to ensure timely and accurate diagnostics
Why This Role Stands Out:
Join one of Indiana's most respected hospital systems with a strong commitment to lab excellence
Night shift autonomy with full support from experienced microbiologists and leadership
Access to modern microbiology technology and instrumentation
Collaborative, mission-driven culture with high job satisfaction
Room to grow: career advancement, internal transfers, and leadership paths available
$62k-92k yearly est. 16d ago
Lab Scientist - Certified (MLS/CLS/MT/MLT)
Parkview Health 4.4
Senior principal scientist job in Fort Wayne, IN
Lab Scientist - Certified (MLS/CLS/MT/MLT) # Certified Lab Scientists are eligible for $10,000 Sign on Bonus! Want to learn more about the unit? Please click#Here## # Summary The Medical Lab Scientist is responsible for accurately performing medical laboratory tests following established laboratory policies and procedures; adhering to performance and quality standards.
The Lab Scientist is responsible for clinical instrument maintenance, for new test and instrumentation development.
The Lab Scientist is responsible for training of other laboratory co- workers.
The Lab Scientist actively participates in the overall functioning of the clinical laboratory, assuming leadership or member roles on committees and projects.
The Lab Scientist is responsible for keeping the laboratory in continuous readiness for inspection.
The Lab Scientist possesses an extensive knowledge of techniques, instruments, and the basic medical sciences.
The Lab Scientist is responsible for the consequences of his/her own decisions and provides guidance to other laboratory co-workers.
Education Bachelor#s degree in chemistry, biology, medical laboratory science, medical technology, or other major that qualifies as an equivalency according to CLIA 42CFR493.
1405(b)(5)(i)(B).
Licensure/Certification At the time of hire or promotion, must be a certified Medical Laboratory Scientist/Medical Technologist (certification by the Board of Registry of the American Society of Clinical Pathology, the National Credentialing Agency, the American Medical Technologists, or the Board of Registry of the American Association of Bioanalysts).
Or Have 1 year of clinical laboratory experience, performing non-waived patient testing and required to pass a nationally recognized certification exams (AMT or ASCP) within 5 years and 6 months from the hire date.
Other Qualifications Must have visual acuity and color discrimination.
Must be able to lift 50 pounds.
Must have good verbal and written communication skills.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API-EM TS/MS (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards. This person interacts daily with a wide variety of people, primarily external partners team members and site management.
The candidate will be responsible for supporting ongoing manufacturing at our External Partners through tasks such as process monitoring, response to issues, and improvements where necessary. A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.
This is a Large Molecule (mAb) position. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.
Responsibilities:
Provide technical oversight for monoclonal antibody manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
Leads resolution of technical issues including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and external relationships.
Build and maintain relationships with development and central technical organizations.
Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Influence and implement the network technical agenda and drive continuous improvement.
Maintaining mAb processes in a state of compliance with US and global regulations
Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of the process and equipment.
Operate with ‘Team Lilly' in mind
Basic Requirements:
Bachelors in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry strongly preferred)
3+ years of demonstrated hands on working experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Preferences:
Strong understanding of regulatory requirements and their application in a manufacturing environment
Proficient in data management practices across manufacturing operations
Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
Proven ability to effectively communicate and influence across diverse technical and business teams
Skilled in managing and delivering complex, cross-functional initiatives
Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects
Additional Information:
Some travel (
Some off-shift work (night/weekend) may be required to support 24/7 operations.
This position is located onsite in Indianapolis, IN and is not approved for remote work. Relocation will be provided.
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 60d+ ago
Lab Scientist - Certified
Parkview Health 4.4
Senior principal scientist job in Fort Wayne, IN
Certified Lab Scientists are eligible for $10,000 Sign on Bonus! Want to learn more about the unit? Please click#Here## # Summary The Medical Lab Scientist is responsible for accurately performing medical laboratory tests following established laboratory policies and procedures; adhering to performance and quality standards.
The Lab Scientist is responsible for clinical instrument maintenance, for new test and instrumentation development.
The Lab Scientist is responsible for training of other laboratory co- workers.
The Lab Scientist actively participates in the overall functioning of the clinical laboratory, assuming leadership or member roles on committees and projects.
The Lab Scientist is responsible for keeping the laboratory in continuous readiness for inspection.
The Lab Scientist possesses an extensive knowledge of techniques, instruments, and the basic medical sciences.
The Lab Scientist is responsible for the consequences of his/her own decisions and provides guidance to other laboratory co-workers.
Education Bachelor#s degree in chemistry, biology, medical laboratory science, medical technology, or other major that qualifies as an equivalency according to CLIA 42CFR493.
1405(b)(5)(i)(B).
Licensure/Certification At the time of hire or promotion, must be a certified Medical Laboratory Scientist/Medical Technologist (certification by the Board of Registry of the American Society of Clinical Pathology, the National Credentialing Agency, the American Medical Technologists, or the Board of Registry of the American Association of Bioanalysts).
Or Have 1 year of clinical laboratory experience, performing non-waived patient testing and required to pass a nationally recognized certification exams (AMT or ASCP) within 5 years and 6 months from the hire date.
Other Qualifications Must have visual acuity and color discrimination.
Must be able to lift 50 pounds.
Must have good verbal and written communication skills.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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.
The LIGM RNA Group is seeking an experienced, independent, and self-motivated scientist with extensive hands-on experience in the analytical characterization and development of oligonucleotides and their conjugates, primarily using LCMS instruments. This is a predominantly lab-based role. The ideal candidate will have a proven track record with liquid chromatography, mass spectrometry, and other advanced analytical techniques. The candidate who has experience with large-scale sample preparation and applying automation to sample preparation or formulation will be a strong plus. In addition, the candidate must demonstrate strong technical problem-solving skills and the ability to quickly learn and apply new technologies or explore new fields. The ability to work independently while delivering high-quality, efficient results in a fast-paced environment is essential.
Responsibilities:
Perform sample preparation for forced degradation and solution stability studies to support developability evaluation at the candidate selection stage for oligonucleotides and their conjugates, including carbohydrates, lipids, small molecules, and others.
Characterize the solubility, and physical and chemical stability of drug candidates and formulations using various analytical techniques, including but not limited to chromatography, mass spectrometry, microscopy, thermal analysis, dynamic light scattering, pharmaceutical particle counting, and backgrounded membrane imaging.
Design and develop LC/LCMS-based methods to elucidate impurities and degradants from API and stability samples.
Partner with the Early Phase TIDES team and the drug discovery team to identify appropriate analytical data packages to support method and project transfers as needed.
Identify and mitigate technical risks affecting the performance and production of drug candidates.
Demonstrate exceptional teamwork and learning agility to solve complex technical problems and to identify and implement novel formulations based on drug delivery technologies that enhance patient benefit and add value to Lilly.
Collaborate with, inspire, and influence the external scientific community to drive innovation, foster collaborations, and strengthen Lilly's internal portfolio.
Continuously refine and improve existing analytical methods and assays, and innovate as necessary to meet evolving program needs.
Rapidly assimilate new technologies and apply cross-disciplinary scientific concepts to address complex analytical challenges.
Maintain thorough, accurate, and timely documentation of experiments, protocols, and results in electronic laboratory notebooks and technical reports.
Ensure high standards of laboratory practice, including compliance with safety and quality guidelines, and promote operational excellence in all analytical activities.
Communicate findings and progress effectively, including regular presentations in project team, department, and governance meetings.
Basic Qualifications:
M.S. in Chemistry, Analytical Chemistry, Biophysics, Biochemistry, or a related field with at least 5 years of experience in analytical characterization using LC/LCMS, OR a B.S. in Chemistry, Analytical Chemistry, Biophysics, Biochemistry, or a related field with at least 8 years of relevant analytical characterization experience using LC/LCMS.
Additional Skills/Preferences:
Strong understanding of biopharmaceutics and pharmacokinetic principles, phase-appropriate formulation development and analytical characterization, pharmaceutical material sciences, and drug product factors that impact in vivo performance and manufacturing.
Demonstrated experience in scale-up sample preparation and analytical characterization of oligonucleotides and their conjugates, as well as biologics.
Proficiency in biophysical and analytical characterization techniques, including but not limited to light scattering methods, chromatography, mass spectrometry, backgrounded membrane imaging, and other molecular-level characterization tools.
Experience in separation sciences, including but not limited to RP, HILIC, HIC, IEX, SEC, and CE.
Expertise in mass spectrometry, including ESI ionization with a range of instrument platforms (QToF, Orbitrap, QQQ).
Experience with analytical development on oligonucleotides and their conjugates is a plus.
Strong teamwork, communication, and scientific writing skills.
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 60d+ ago
Lab Scientist - Certified
Dekalb Health 4.4
Senior principal scientist job in Fort Wayne, IN
Certified Lab Scientists are eligible for $10,000 Sign on Bonus! Want to learn more about the unit? Please click Here The Medical Lab Scientist is responsible for accurately performing medical laboratory tests following established laboratory policies and procedures; adhering to performance and quality standards. The Lab Scientist is responsible for clinical instrument maintenance, for new test and instrumentation development. The Lab Scientist is responsible for training of other laboratory co- workers. The Lab Scientist actively participates in the overall functioning of the clinical laboratory, assuming leadership or member roles on committees and projects. The Lab Scientist is responsible for keeping the laboratory in continuous readiness for inspection. The Lab Scientist possesses an extensive knowledge of techniques, instruments, and the basic medical sciences. The Lab Scientist is responsible for the consequences of his/her own decisions and provides guidance to other laboratory co-workers.
Education
Bachelor's degree in chemistry, biology, medical laboratory science, medical technology, or other major that qualifies as an equivalency according to CLIA 42CFR493.1405(b)(5)(i)(B).
Licensure/Certification
At the time of hire or promotion, must be a certified Medical Laboratory Scientist/Medical Technologist (certification by the Board of Registry of the American Society of Clinical Pathology, the National Credentialing Agency, the American Medical Technologists, or the Board of Registry of the American Association of Bioanalysts).
Or
Have 1 year of clinical laboratory experience, performing non-waived patient testing and required to pass a nationally recognized certification exams (AMT or ASCP) within 5 years and 6 months from the hire date.
Other Qualifications
Must have visual acuity and color discrimination. Must be able to lift 50 pounds. Must have good verbal and written communication skills.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 49,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is passionate about the discovery, development and commercialization of potential new medicines that will impact and improve the lives of patients. Lilly Genetic Medicines is an innovation-focused organization striving to identify, develop and apply the most cutting-edge technologies to deliver maximum benefit to our patients. Our agile and diverse team strives to operate as an autonomous ‘biotech-like' company within the walls of Lilly.
The Lilly Genetic Medicines (LGM) Team is looking for a collaborative, creative, and energetic problem solver to join a multidisciplinary team at the front edge of innovation. They will join our fast-paced, interdisciplinary team as we utilize novel RNA/oligonucleotide based therapeutic modalities to enhance the Lilly portfolio. The successful applicant will utilize their knowledge and technical expertise to accelerate the core capabilities of large-scale oligonucleotide synthesis of internal RNAi-based clinical candidates. Are you skilled in large-scale oligonucleotide synthesis and interested in learning about RNAi discovery and development for impactful patient therapies? We want you on our team!
Responsibilities:
Lead the Lilly Genetic Medicines discovery oligosynthesis scale-up team to accelerate Lilly RNAi Therapeutics from pre-clinical to clinical development
Utilize comprehensive expertise in oligonucleotide synthesis methodologies to support Lilly Genetic Medicines and further develop internal capabilities and team growth through effective coaching, mentorship, and leadership.
Collaborate with members of the RNAi discovery chemistry teams to validate and execute requirements for oligonucleotide synthesis from 150umol to 6mmol scales including communication of relevant information and results to project leads and/or cross-functional organizations within Lilly to ensure seamless operation of the scale-up team.
Actively support our efforts toward the discovery of lead drug candidates and lead at the interface with our CMC and Development teams to provide essential materials for key studies and effectively communicate technical insights to the development team.
Demonstrate expertise in modern synthetic organic and nucleic acid chemistry, striving to improve methods, develop new technologies, and address synthetic oligonucleotide challenges across a diverse portfolio
Oversee and prioritize the work of scale-up team members to meet critical timelines.
Value diverse perspectives and experiences for effective solutions. Motivate team members to take initiative, own outcomes, and share expertise on complex technical challenges.
Guide teams through unclear situations, adapt efficiently to changes, and evaluate and implement effective approaches to completing tasks.
Basic Qualifications:
Master's degree in Chemistry, Biochemistry or a relevant scientific field with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis) OR Bachelor's degree in Chemistry, Biochemistry or a relevant scientific field with 8+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis).
Preferred Qualifications:
Strong laboratory skills and experience with analytical instrumentation such as AKTA, Agilent LC-MS and UPLC, Vanquish LTQ, Water's QDA, etc.
Experience in supervising a team of scientists to evaluate, refine and execute synthetic routes, technologies, and practices to deliver LGM portfolio
Experience in troubleshooting and optimizing synthetic protocols on automated solid-phase synthesis instruments
Experience with downstream processing of oligonucleotides including use of chromatographic purification and process TFF systems
Experience in developing new chromatographic methods (IEX/RP-HPLC, SPE, LC-MS).
Experience in conjugation of novel ligands, including small molecules, peptides, and proteins to oligonucleotides at 5-25g scale
Ability to function within a highly interdisciplinary environment
Excellent written and oral communication skills, good organizational skills, the ability to multitask, and lead a team to deliver on tight deadlines
Confident, execution-focused, and team-oriented with a desire to thrive in a fast-paced growing environment is a plus.
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 60d+ ago
Lab Scientist - Certified (MLS/CLS/MT/MLT)
Dekalb Health 4.4
Senior principal scientist job in Fort Wayne, IN
Certified Lab Scientists are eligible for $10,000 Sign on Bonus! Want to learn more about the unit? Please click Here The Medical Lab Scientist is responsible for accurately performing medical laboratory tests following established laboratory policies and procedures; adhering to performance and quality standards. The Lab Scientist is responsible for clinical instrument maintenance, for new test and instrumentation development. The Lab Scientist is responsible for training of other laboratory co- workers. The Lab Scientist actively participates in the overall functioning of the clinical laboratory, assuming leadership or member roles on committees and projects. The Lab Scientist is responsible for keeping the laboratory in continuous readiness for inspection. The Lab Scientist possesses an extensive knowledge of techniques, instruments, and the basic medical sciences. The Lab Scientist is responsible for the consequences of his/her own decisions and provides guidance to other laboratory co-workers.
Education
Bachelor's degree in chemistry, biology, medical laboratory science, medical technology, or other major that qualifies as an equivalency according to CLIA 42CFR493.1405(b)(5)(i)(B).
Licensure/Certification
At the time of hire or promotion, must be a certified Medical Laboratory Scientist/Medical Technologist (certification by the Board of Registry of the American Society of Clinical Pathology, the National Credentialing Agency, the American Medical Technologists, or the Board of Registry of the American Association of Bioanalysts).
Or
Have 1 year of clinical laboratory experience, performing non-waived patient testing and required to pass a nationally recognized certification exams (AMT or ASCP) within 5 years and 6 months from the hire date.
Other Qualifications
Must have visual acuity and color discrimination. Must be able to lift 50 pounds. Must have good verbal and written communication skills.
$43k-51k yearly est. 5d ago
Scientist - API Manufacturing Process Support
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Overview
The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM 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 technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct 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.
Provide support internal and joint process teams and to the global and local PLOT teams.
Ability to independently set up and execute various chemical reactions.
Ensure that experiments are well designed with clear objectives.
Ability to analyze data and ensure appropriate documentation.
Utilize save laboratory practice and adhere to CHP requirements.
Write technical reports and documents.
Basic Requirements:
Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.
or
Master's Degree and 1 year experience in cGMP manufacturing.
Additional Preferences:
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.
Demonstrated basic knowledge in small or large molecule API Manufacturing.
Familiarity with cGMP manufacturing environment and terminology.
Excellent analytical, interpersonal, written and oral communication skills.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.
Additional Information:
Tasks require entering manufacturing areas which require wearing appropriate PPE.
Domestic and international Travel (variable, can approach 20%).
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 12d ago
Lab Scientist - Certified (MLS/CLS/MT/MLT)
Parkview Health 4.4
Senior principal scientist job in Bryan, OH
Certified Lab Scientists are eligible for $10,000 Sign on Bonus! Want to learn more about the unit? Please click#Here## # Summary The Medical Lab Scientist is responsible for accurately performing medical laboratory tests following established laboratory policies and procedures; adhering to performance and quality standards.
The Lab Scientist is responsible for clinical instrument maintenance, for new test and instrumentation development.
The Lab Scientist is responsible for training of other laboratory co- workers.
The Lab Scientist actively participates in the overall functioning of the clinical laboratory, assuming leadership or member roles on committees and projects.
The Lab Scientist is responsible for keeping the laboratory in continuous readiness for inspection.
The Lab Scientist possesses an extensive knowledge of techniques, instruments, and the basic medical sciences.
The Lab Scientist is responsible for the consequences of his/her own decisions and provides guidance to other laboratory co-workers.
Education Bachelor#s degree in chemistry, biology, medical laboratory science, medical technology, or other major that qualifies as an equivalency according to CLIA 42CFR493.
1405(b)(5)(i)(B).
Licensure/Certification At the time of hire or promotion, must be a certified Medical Laboratory Scientist/Medical Technologist (certification by the Board of Registry of the American Society of Clinical Pathology, the National Credentialing Agency, the American Medical Technologists, or the Board of Registry of the American Association of Bioanalysts).
Or Have 1 year of clinical laboratory experience, performing non-waived patient testing and required to pass a nationally recognized certification exams (AMT or ASCP) within 5 years and 6 months from the hire date.
Other Qualifications Must have visual acuity and color discrimination.
Must be able to lift 50 pounds.
Must have good verbal and written communication skill
$30k-36k yearly est. 60d+ ago
Sr./Principle Scientist - TSMS Small Molecule External Manufacturing
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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.
Company Overview
Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better - through medicines and information - for some of the world's most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees - people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team - and make a difference in improving health for people all over the world!
Job Description
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Sr. PrincipleScientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The role is focused on ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the Small Molecule portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.
Key Objectives/Deliverables:
Provide technical oversight and stewardship for Small Molecule manufacturing processes.
Leads resolution of technical issues including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and external relationships.
Build and maintain relationships with development and central technical organizations.
Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
Optimize and execute site control strategies.
Successfully deliver on strategic initiatives.
Influence and implement the network technical agenda and drive continuous improvement.
Maintaining processes in a state of compliance with US and global regulations
Understanding the scientific principles required for manufacturing drug substances, including the interaction of chemistry and equipment.
Operate with ‘Team Lilly' in mind - including coaching and mentoring of peers and other scientists.
Basic Requirements:
Master's Degree or higher in scientific discipline of Chemistry or related fields, and 8 + years industry experience.
Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Information
Occasional travel required 5 - 15%.
LOCATION:
Onsite in Indianapolis, US
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
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. #WeAreLilly
Position Brand Description:
The Scientist positions in the Technical Services / Manufacturing Sciences - Sterility Assurance Technology (TS / MS - SAT) group are positions that provide support for control of the site's manufacturing facilities. The group develops and implements sterility assurance related initiatives and provides technical leadership with regard to sterility assurance strategies.
Responsibilities:
Ensure site's Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management, and other sterility assurance programs are followed at the manufacturing Flow level.
Provide technical guidance to the Flow and Process Teams for sterility assurance programs.
Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
Lead or provide technical support for root cause investigations for sterility assurance programs.
Use of sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk.
Lead site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Create, execute, review and/or approve technical documents related to sterility assurance programs including risk assessments, justification documents, protocols, and summary reports.
Create, execute and/or review change controls related to sterility assurance programs.
Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.
Participate in continuous improvement projects to improve quality performance at the site.
Participate or provide guidance for sterility assurance programs during regulatory audits.
Provide content and/or data integrity reviews for regulatory submissions.
Lead training courses related to sterility assurance programs.
Basic Qualifications:
Bachelor's degree in Microbiology, Biology, or other STEM related discipline in conjunction with relevant experience.
Additional Skills/Preferences:
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Understanding of GMPs and applicable internal standards
Parenteral Manufacturing experience
Communication (oral and written) skills; technical writing skills
Teamwork / interpersonal skills
Experience with data trending and analysis
Analysis and problem solving skills
Quality orientation
Ability to effectively influence
Additional Information:
8 hour days - Monday through Friday
Overtime may be required
Work in a dynamic and fast-paced environment
5 - 10% Travel Required
Applicant will work in various areas within the Parenteral Site. Some allergens are present.
Applicant will be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
On call support 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 49d ago
AI Scientist - Simulation & Forecasting
Eli Lilly and Company 4.6
Senior principal scientist job in Gas City, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, 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.
As an AI Scientistin Indianapolis, IN, you will analyze complex data sets, develop simulation models, leverage foundation models, and identify insights that can drive business decisions. You will work closely with cross-functional teams across the enterprise to understand business problems, develop hypotheses, and test those hypotheses with data.
How You'll Succeed:
Develop and implement machine learning algorithms to analyze large data sets
Collaborate with stakeholders to understand business problems and provide data-driven solutions
Communicate insights and recommendations to technical and non-technical stakeholders
Conduct research to identify emerging trends and technologies
Manage and prioritize multiple projects simultaneously
What You Will Do:
Frame and solve complex business problems with simulation and AI
Develop and implement scenario planning models
Communicate insights and recommendations to stakeholders
Collaborate with cross-functional teams
Stay up-to-date with emerging trends and technologies in simulation and AI
Ensure data quality and accuracy
Your Basic Requirements:
Ph.D. in Computer Science, Applied Mathematics focusing on Numerical Analysis, High Performance Computing, Operations Research, Physics, Engineering, or a quantitative related field
Or MS in Computer Science, Applied Mathematics focusing on Numerical Analysis, High Performance Computing, Operations Research, Physics, Engineering, or a quantitative related field with at least 5 years of related working experience developing simulation models and leveraging foundation models or forecasting.
Experience with simulation and machine learning
Proficiency in programming languages such as Python or R
What You Should Bring:
Experience with deep learning algorithms and reinforcement learning
Excellent communication and presentation skills
People management or consulting experience
Experience with simulation platforms like Anylogic
Experience in consulting, bio-tech, finance, or pharmaceutical
Other:
Must be willing to relocate.
Schedule will be hybrid (3 days onsite at the Lilly Corporate Center)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $244,200
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
How much does a senior principal scientist earn in Fort Wayne, IN?
The average senior principal scientist in Fort Wayne, IN earns between $87,000 and $173,000 annually. This compares to the national average senior principal scientist range of $83,000 to $169,000.
Average senior principal scientist salary in Fort Wayne, IN