Principal Scientist Raw Materials Lilly Medicine Foundry

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.
• Afford 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.
• 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.
• Partner with the Advisor on continuous improvement of test methods, lab workflows, and digital systems (LIMS/ELN/LabVantage configuration, automation).

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.

Qualifications

• 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.