Senior Tech Services & Manufacturing Sciences Lead

Eli Lilly and Company; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Job summary

Eli Lilly and Company, headquartered in Indianapolis, seeks a Technical Services/Manufacturing Sciences (TS/MS) Lead to provide technical leadership and scientific support for drug substance/product manufacturing, ensuring robust, compliant operations, continuous process improvement, and successful technology transfer and lifecycle management.

You will collaborate with R&D, Quality, Manufacturing, Engineering, and Regulatory Affairs, lead audits, mentor staff, and stay current on industry trends

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 7+ years in pharma/biotech with focus on manufacturing science/technical services.

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.

Education

Bachelor's degree in Chemical Eng

Job description

Eli Lilly and Company, headquartered in Indianapolis, seeks a Technical Services/Manufacturing Sciences (TS/MS) Lead to provide technical leadership and scientific support for drug substance/product manufacturing, ensuring robust, compliant operations, continuous process improvement, and successful technology transfer and lifecycle management.

You will collaborate with R&D, Quality, Manufacturing, Engineering, and Regulatory Affairs, lead audits, mentor staff, and stay current on industry trends