Parenteral Commercialization Technology Transfer Lead
Eli Lilly and Company
4 hours ago
Remote friendly (Durham, NC)
United States
Operations
Position: Parenteral Commercialization Technology Transfer Lead (Individual Contributor)
Responsibilities
- Serve as manufacturing technology transfer lead for transfer of new molecules and commercial products to internal Lilly sites or external contract manufacturers.
- Provide strategic oversight from late-stage development through process validation and launch readiness (aligned with global manufacturing, regulatory, and quality strategies).
- Drive process validation strategy, design, and execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decisions throughout the transfer lifecycle.
- Author/co-author technology transfer documents and contribute commercial manufacturing sections for regulatory submissions.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure alignment and consistency.
- Partner to develop manufacturing control strategies for seamless scale-up and commercial readiness across global sites.
- Own the technical interface between the technology transfer team and CMC team (control strategy, process design, submission readiness).
- Present technology transfer status, risks, and technical decisions at governance forums and stage gate reviews.
- Lead/co-lead technology transfer meetings; facilitate post-validation handoff to Site Operations and Manufacturing CMC teams.
Basic Requirements / Qualifications
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
- Manufacturing experience in commercialization and technology transfer of parenteral and/or device combination products.
- Manufacturing experience supporting commercial manufacturing.
- Excellent written and oral communication skills.
- Understanding of cGMPs, policies, procedures, and guidelines.
- Demonstrated technical leadership of cross-functional teams.
- Technical knowledge of parenteral products and control strategies.
- Strong interpersonal/teamwork, self-management, and organizational skills.
- Accountable for supporting HSE Corporate Goals and maintaining a safe work environment.
Additional Preferences
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Risk-based approaches to process development.
- Regulatory submission strategies/processes (e.g., BLA, NDA, PAS, CBE; site transfers).
- Data analytics/visualization and/or AI tools; comfort using digital collaboration tools.
- Operational excellence through process improvement/standardization/lean methodologies.
- Experience with teamwork processes and knowledge management.
Other Information
- Some travel (domestic and international) up to 25%.
Benefits (explicitly listed)
- Eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription drug; flexible benefits; life insurance and death benefits; certain time off and leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
- Serve as manufacturing technology transfer lead for transfer of new molecules and commercial products to internal Lilly sites or external contract manufacturers.
- Provide strategic oversight from late-stage development through process validation and launch readiness (aligned with global manufacturing, regulatory, and quality strategies).
- Drive process validation strategy, design, and execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decisions throughout the transfer lifecycle.
- Author/co-author technology transfer documents and contribute commercial manufacturing sections for regulatory submissions.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure alignment and consistency.
- Partner to develop manufacturing control strategies for seamless scale-up and commercial readiness across global sites.
- Own the technical interface between the technology transfer team and CMC team (control strategy, process design, submission readiness).
- Present technology transfer status, risks, and technical decisions at governance forums and stage gate reviews.
- Lead/co-lead technology transfer meetings; facilitate post-validation handoff to Site Operations and Manufacturing CMC teams.
Basic Requirements / Qualifications
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
- Manufacturing experience in commercialization and technology transfer of parenteral and/or device combination products.
- Manufacturing experience supporting commercial manufacturing.
- Excellent written and oral communication skills.
- Understanding of cGMPs, policies, procedures, and guidelines.
- Demonstrated technical leadership of cross-functional teams.
- Technical knowledge of parenteral products and control strategies.
- Strong interpersonal/teamwork, self-management, and organizational skills.
- Accountable for supporting HSE Corporate Goals and maintaining a safe work environment.
Additional Preferences
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Risk-based approaches to process development.
- Regulatory submission strategies/processes (e.g., BLA, NDA, PAS, CBE; site transfers).
- Data analytics/visualization and/or AI tools; comfort using digital collaboration tools.
- Operational excellence through process improvement/standardization/lean methodologies.
- Experience with teamwork processes and knowledge management.
Other Information
- Some travel (domestic and international) up to 25%.
Benefits (explicitly listed)
- Eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription drug; flexible benefits; life insurance and death benefits; certain time off and leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Full-time employees may be eligible for a company bonus (depending on company and individual performance).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation