Principal - QA API External Manufacturing Peptides

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.

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's Active Pharmaceutical Ingredient External Manufacturing (API-EM) organization oversees the production of large molecule and biologics APIs at contract manufacturing sites worldwide

• Provide QA oversight of external API manufacturing, including batch disposition, deviation management, and change control.
• Conduct and support audits to ensure compliance with cGMP regulations and Lilly quality standards.
• Review and approve quality documentation, including batch records, validation documents, stability data, and analytical methods.
• Partner with internal functions and external manufacturers to resolve quality issues and drive continuous improvement.
• Support new product introductions, technology transfers, and quality agreement management.
• Lead investigations of quality events, deviations, and OOS results, identifying root causes and implementing CAPAs.

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or science related field.
• 5+ years of pharmaceutical or biopharmaceutical industry experience, with a strong emphasis in QA, preferably supporting API manufacturing and external supply.
• Experience supporting GMP manufacturing operations in a QA shop floor environment.
• Strong knowledge of cGMP regulations and global quality requirements.
• Ability to travel domestically and internationally as needed.

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.

• Strong understanding of API manufacturing processes, analytical testing, and quality control principles.
• Strong preference for candidates with hands‑on experience supporting biologics, large molecule, or peptide (TIDES) drug substance manufacturing.
• QA shop floor experience.
• Excellent problem‑solving, decision‑making, and communication skills, with the ability to convey complex quality and technical information effectively.

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