Parenteral Commercialization Technology Transfer Lead
Eli Lilly and Company
4 hours ago
On-site
Kenosha, WI
Operations
The Parenteral Commercialization Technology Transfer Lead provides technical leadership during technology transfers of parenteral drug product new molecular entities and existing commercial products to internal Lilly sites or external contract manufacturers. Partners with development, engineering, regulatory, and quality to design and oversee the technology transfer plan, studies, and supporting activities, and aligns commercialization practices and study designs with the Global Commercialization Steward and Global Molecule Stewards. Individual contributor in a scientific track.
Key Objectives/Deliverables:
- 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.
- 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 decisions throughout the transfer lifecycle.
- Author/co-author technology transfer documents and regulatory submission sections related to commercial manufacturing.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure process alignment.
- Develop manufacturing control strategies with development, Global Molecule Stewards, and Global Platform Stewards for global scale-up and readiness.
- Own the technical interface between the technology transfer team and CMC team for control strategy, process design, and submission readiness.
- Present status, risks, and technical decisions at governance forums and stage gate reviews; lead/co-lead meetings.
- Facilitate post-validation handoff to Site Operations and Manufacturing CMC Teams for commercial production and lifecycle management.
Basic Requirements:
- 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; and 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.
- Maintain a safe work environment and support all HSE Corporate Goals.
Additional Preferences:
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Familiarity with risk-based approaches to process development.
- Familiarity with regulatory submission strategies and licensure requirements (e.g., BLA, NDA, PAS/CBE, site transfers).
- Experience with data analytics, visualization, and/or AI tools; comfortable with digital tools.
- Track record driving operational excellence via process improvement/standardization/lean.
- Experience implementing/improving teamwork processes and knowledge management.
Other Information:
- Some travel (domestic and international) required (up to 25%).
- Benefits (eligible employees): company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., EAP, fitness, clubs/activities).
Key Objectives/Deliverables:
- 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.
- 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 decisions throughout the transfer lifecycle.
- Author/co-author technology transfer documents and regulatory submission sections related to commercial manufacturing.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure process alignment.
- Develop manufacturing control strategies with development, Global Molecule Stewards, and Global Platform Stewards for global scale-up and readiness.
- Own the technical interface between the technology transfer team and CMC team for control strategy, process design, and submission readiness.
- Present status, risks, and technical decisions at governance forums and stage gate reviews; lead/co-lead meetings.
- Facilitate post-validation handoff to Site Operations and Manufacturing CMC Teams for commercial production and lifecycle management.
Basic Requirements:
- 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; and 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.
- Maintain a safe work environment and support all HSE Corporate Goals.
Additional Preferences:
- Experience managing technology transfers to external contract manufacturers (CMOs).
- Familiarity with risk-based approaches to process development.
- Familiarity with regulatory submission strategies and licensure requirements (e.g., BLA, NDA, PAS/CBE, site transfers).
- Experience with data analytics, visualization, and/or AI tools; comfortable with digital tools.
- Track record driving operational excellence via process improvement/standardization/lean.
- Experience implementing/improving teamwork processes and knowledge management.
Other Information:
- Some travel (domestic and international) required (up to 25%).
- Benefits (eligible employees): company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., EAP, fitness, clubs/activities).