Associate Director- Technical Services​/Manufacturing Science Lead

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.

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.

** Job 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.

** Job Qualifications*
* + 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.

** Additional Preferences*
* + 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.

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