Principal Scientist Raw Materials Lilly Medicine Foundry

Lilly • Indianapolis, IN

1d • $65,250 - $169,400 • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The 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.

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 and 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.

Nice To Haves

• 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.

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).

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal