Parenteral Commercialization Technology Transfer Lead
Eli Lilly and Company
5 hours ago
On-site
Concord, NC
Operations
Parenteral Commercialization Technology Transfer Lead (Individual Contributor)
Responsibilities / Key Objectives:
- 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; align with global manufacturing, regulatory, and quality strategies.
- Drive process validation strategy, design, and execution; ensure successful handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decision-making.
- Author/co-author technology transfer documents and contribute to regulatory submissions’ commercial manufacturing sections.
- Coordinate technology transfer activities across receiving sites and/or external manufacturing partners to ensure process alignment and consistency.
- Partner with development, Global Molecule Stewards, and Global Platform Stewards to develop manufacturing control strategies for global scale-up and readiness.
- Own the technical interface between technology transfer and CMC teams; align on control strategy, process design, and 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 for commercial production and lifecycle management.
Required 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.
- Ability to maintain a safe work environment and support HSE Corporate Goals.
Preferred Qualifications:
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Familiarity with risk-based approaches to process development.
- Familiarity with regulatory submission strategies/processes and licensure requirements (e.g., BLA, NDA, PAS/CBE, site transfers).
- Experience with data analytics/visualization and/or AI tools; comfort with digital tools to improve collaboration.
- Track record driving operational excellence (process improvement, standardization, lean).
- Experience implementing/improving teamwork processes and knowledge management.
Education Requirements:
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
Travel:
- Up to 25% domestic and international travel.
Compensation and Benefits (as stated):
- Anticipated base pay: $102,000 - $209,000.
- Potential company bonus for full-time employees (based on company/individual performance).
- Eligibility for comprehensive benefit program, including company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription drug, flexible benefits, life insurance, time off/leave benefits, and well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions / Other Info:
- If you require an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities / Key Objectives:
- 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; align with global manufacturing, regulatory, and quality strategies.
- Drive process validation strategy, design, and execution; ensure successful handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decision-making.
- Author/co-author technology transfer documents and contribute to regulatory submissions’ commercial manufacturing sections.
- Coordinate technology transfer activities across receiving sites and/or external manufacturing partners to ensure process alignment and consistency.
- Partner with development, Global Molecule Stewards, and Global Platform Stewards to develop manufacturing control strategies for global scale-up and readiness.
- Own the technical interface between technology transfer and CMC teams; align on control strategy, process design, and 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 for commercial production and lifecycle management.
Required 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.
- Ability to maintain a safe work environment and support HSE Corporate Goals.
Preferred Qualifications:
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Familiarity with risk-based approaches to process development.
- Familiarity with regulatory submission strategies/processes and licensure requirements (e.g., BLA, NDA, PAS/CBE, site transfers).
- Experience with data analytics/visualization and/or AI tools; comfort with digital tools to improve collaboration.
- Track record driving operational excellence (process improvement, standardization, lean).
- Experience implementing/improving teamwork processes and knowledge management.
Education Requirements:
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
Travel:
- Up to 25% domestic and international travel.
Compensation and Benefits (as stated):
- Anticipated base pay: $102,000 - $209,000.
- Potential company bonus for full-time employees (based on company/individual performance).
- Eligibility for comprehensive benefit program, including company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription drug, flexible benefits, life insurance, time off/leave benefits, and well-being benefits (e.g., employee assistance program, fitness benefits).
Application Instructions / Other Info:
- If you require an accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation