Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (Peptides)

Eli Lilly and Company • Indianapolis, IN

6d • Onsite

About The Position

Eli Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing in Peptides. In this role, you will provide critical technical leadership and scientific expertise to ensure the robust and compliant manufacturing of peptide drug substances, from process development through commercialization and life cycle management.

Requirements

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline
• 8+ years of relevant experience in manufacturing within the pharmaceutical or biotechnology industry
• Proven leadership experience, including direct supervision and mentorship of scientific and technical staff.

Nice To Haves

• Strong understanding of cGMP regulations, ICH guidelines, and regulatory expectations for pharmaceutical manufacturing.
• Demonstrated ability to troubleshoot complex manufacturing issues and implement robust solutions.
• Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and concisely to diverse audiences.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Ability to work effectively in a fast-paced, dynamic, and highly collaborative environment.
• Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred.

Responsibilities

• Lead and manage a team of scientists, providing technical guidance, mentorship, and performance management to achieve departmental goals.
• Serve as the primary technical leader for peptide manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving continuous improvement initiatives.
• Oversee the transfer of new peptide processes from development to manufacturing, ensuring successful scale-up, validation, and regulatory compliance.
• Design, execute, and interpret experiments to optimize existing peptide manufacturing processes, enhance yield, reduce cost, and improve product quality.
• Author and review technical reports, protocols, and regulatory submissions related to peptide manufacturing processes and product quality.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and product delivery.
• Lead investigations into manufacturing deviations, non-conformances, and out-of-specification results, implementing effective corrective and preventive actions (CAPAs).
• Stay abreast of industry best practices, emerging technologies, and regulatory requirements related to peptide manufacturing and analytical methods.
• Present technical findings and recommendations to senior leadership and external stakeholders.

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: Manager