Associate Director- Technical Services/Manufacturing Science Lead

Eli Lilly and Company • Us, IN

6d • Onsite

About The Position

The Technical Services/Manufacturing Sciences (TS/MS) Lead at Eli Lilly RLT provides technical leadership and scientific support for drug substance/product manufacturing, ensuring robust, compliant operations, continuous process improvement, and successful technology transfer and lifecycle management.

Requirements

• Bachelor's degree in Chemical Engineering, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of experience in the pharmaceutical or biotechnology industry, with a strong focus on manufacturing science, process development, or technical services.

Nice To Haves

• Strong understanding of cGMP regulations, ICH guidelines, and related regulatory requirements.
• Experience with technology transfer and process validation.
• Proven track record leading complex technical projects and solving challenging manufacturing issues.
• Strong problem-solving and critical thinking skills.
• Excellent written and verbal communication, with ability to explain complex technical information to diverse audiences.
• Collaborative, team-oriented approach to cross-functional work.
• Experience in Radioligand Therapies highly preferred.

Responsibilities

• Lead investigations into deviations and non-conformances, determining root causes and implementing CAPAs.
• Provide scientific and technical leadership for drug substance/product manufacturing, including process monitoring, troubleshooting, and optimization.
• Drive continuous improvement initiatives to enhance process performance, yield, cost, and compliance, and define/sustain the control strategy for a robust, reliable process.
• Support technology transfer for new products, processes, or sites, ensuring successful implementation.
• Develop and execute process validation strategies, including continued process verification (CPV).
• Author and review technical reports, protocols, and regulatory submission documents (e.g., CMC sections).
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Engineering, and Regulatory Affairs.
• Lead the sterility assurance team and its responsibilities.
• Mentor junior scientists and engineers within the TS/MS team.
• Lead or support internal/external audits and inspections with technical expertise.
• Stay current on industry trends, technologies, and regulatory requirements in manufacturing science.

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