Organization and Position OverviewLilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The Principal Scientist, Raw Materials is the on-the-bench subject matter expert supporting the Advisor of Raw Materials in day-to-day analytical testing and release of raw materials for clinical and commercial GMP manufacturing at the Medicine Foundry Analytical GMP Laboratory. The Principal Scientist executes and oversees compendial and non-compendial testing, authors change controls and investigations, supports the raw material certification program, and will train and mentor junior analysts. Partnering with the Advisor, Quality Assurance, Manufacturing, Supply Chain, and external suppliers, the Principal Scientist contributes to root cause analysis, method transfers, and inspection readiness in compliance with cGMP, data integrity (ALCOA+), and regulatory requirements.
Responsibilities- Perform and oversee analytical testing of GMP raw materials, including compendial (USP, EP, JP, ChP) and non-compendial test methods; serve as technical SME for analytical data review, supporting accurate and timely disposition to meet manufacturing schedules.
- Execute laboratory operations in compliance with cGMP, data integrity (ALCOA+) principles, applicable regulatory requirements, and internal SOPs, including review of analytical data and laboratory notebooks.
- Lead laboratory investigations for out-of-specification (OOS), out-of-trend (OOT), and atypical results in coordination with the Advisor; author investigation reports, support root cause analysis, and track CAPAs to closure with Quality Assurance.
- Support the Advisor in execution of the raw material certification program, including supplier qualification and requalification, CoA review and correlation studies, reduced testing eligibility assessments, periodic re-evaluation, and maintenance of the certified material list and associated quality agreements.
- Assist in developing and delivering training for junior analysts on raw material test methods, cGMP, data integrity (ALCOA+), and laboratory documentation; serve as on-the-bench mentor and qualification trainer, assess analyst proficiency, and support the Advisor in maintaining training records and qualification matrices in support of inspection readiness.
- Author change controls for raw material specifications, test methods, and SOPs; assess change impact, support definition of implementation and verification activities, and support cross-functional approval.
- Serve as on-the-bench SME during internal audits and regulatory inspections (FDA, EMA, etc.), supporting back-room preparation and responding to inspector questions; assist with remediation of audit observations.
- Handle hazardous materials, solvents, and reagents in accordance with EHS requirements; maintain a clean and compliant laboratory environment per 5S/lean lab practices.
- Partner with the Advisor on continuous improvement of test methods, lab workflows, and digital systems (LIMS/ELN/LabVantage configuration, automation).
Basic Requirements:- BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
- BS with 5-10 years or MS with 3+ years of experience in cGMP analytical laboratory experience, including authoring change controls and investigations, mentoring analysts, and supporting a raw material certification or supplier qualification program.
- Previous experience with raw materials testing, sampling, and release in a GMP-regulated pharmaceutical or biotech laboratory.
- Proficient in compendial test methods, including Raman, FTIR, UV-Vis, HPLC, GC, Karl Fischer titration, and wet chemistry techniques.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences: - Prior work with electronic laboratory notebooks (ELN), LIMS, LabVantage, and chromatography data systems (e.g., Empower, Chromeleon).
- Proficient in interpreting and applying USP, EP, JP, and ICH guidelines to raw material specifications and testing.
- Experience assisting with the development of qualification curricula and on-the-job training plans.
Other Information:- Initial location at Lilly Technology Center, Indianapolis or Parkwood West, Indianapolis
- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
- Travel: Less than 5% domestic
- Shift: First shift with occasional off-shift, weekend, or holiday coverage to support manufacturing demand.
- Physical: Ability to handle hazardous chemicals and solvents while wearing required PPE, stand for extended periods, and perform laboratory work in a gowned environment.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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