Position: Scientist – Process Translation and Execution (PTE) Team
The PTE team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements control strategies, and ensures right‑first‑time clinical manufacturing for various modalities. The role is part of the Lilly Medicine Foundry construction and start‑up phase (2025‑2028), requiring collaboration, creativity, and resilience to support operational readiness and site culture.
Responsibilities
- Facilitate the transfer of chemical processes for bioconjugation to produce ADCs and similar modalities from development laboratories to pilot plant operations.
- Perform bioconjugation chemistry, antibody preparation, buffer exchanges, and protein characterization (DAR analysis, aggregate assessment).
- Apply multiple conjugation strategies (maleimide, click, enzymatic).
- Work with highly potent molecules, containment, and single‑use bioprocessing systems.
- Mentor less experienced scientists and supervise colleagues.
- Collaborate cross‑functionally across engineers, analytical chemists, chemical technicians, safety and quality representatives.
- Receive chemistry from early‑phase R&D labs and evaluate safety in collaboration with safety group and process engineering.
- Ensure raw material and reagent readiness; participate in setting up analytical methods.
- Reprocess and analyze analytical data for fact‑based decisions.
- Summarize and present chemistry and challenges.
- Conduct familiarization reactions (reduction, conjugation, oxidation) and Tangential Flow Filtration (TFF) operations at the Foundry.
- Use‑test key raw materials and document Definitive Lab Trials to confirm plant readiness.
- Maintain detailed, organized lab notebooks and technical packages for transfer.
- Author, review, and maintain technical documents (tech transfer plan, SOPs, batch records, campaign summary reports, deviation reports).
- Identify process improvement opportunities and implement new technologies or procedures.
- Contribute to troubleshooting, root‑cause analysis, corrective and preventive actions (CAPAs).
Basic Requirements
- B.S. or M.S. with 6+ years of manufacturing experience (biochemistry, chemical biology, conjugation chemistry, chemical engineering) or Ph.D. with 2+ years of experience.
Additional Preferences
- Working knowledge of organic chemistry mechanisms and reaction optimization.
- Experience with analytical methods for small molecules and biocompounds (RP‑HPLC, SEC, IEX, HIC, LC‑MS, CE‑SDS).
- Hands‑on liquid chromatography for bioconjugate purification and familiarity with chromatography systems.
- Experience with synthetic chemistry for scale‑up and process chemistry concepts.
- Comfortable with larger glass equipment and single‑use equipment.
- Proven ability to lead technology transfer end‑to‑end from lab to clinical manufacturing.
- Experience creating batch records and conducting scale‑up experiments.
- Ability to prioritize multiple activities and manage ambiguity.
- Process quantification and mass‑balance acquisition.
- Drive projects and adapt to change.
- Excellent written and verbal communication for technical reports and presentations.
- Proven problem‑solving, root‑cause analysis, and resolution of technical challenges.
- Collaborative capability across disciplines and levels.
Other Information
- Initial location: Lilly Technology Center, Indianapolis.
- Permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
- Domestic and international travel (<5%) may be required.
- Requires working in manufacturing and laboratory environments.
Compensation and Benefits
Compensation range: $129,000 – $209,000 per year. Full‑time employees are eligible for a company bonus, 401(k), pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits (healthcare and/or dependent day‑care FSA), life insurance, death benefits, time off and leave of absence, and well‑being benefits.
Equal Employment Opportunity
Lilly is an equitable employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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