Parenteral Commercialization Technology Transfer Lead
Eli Lilly and Company
6 hours ago
On-site
Pleasant Prairie, WI
Operations
Parenteral Commercialization Technology Transfer Lead (Scientific individual contributor)
Responsibilities
- Lead technical activities during technology transfers of parenteral drug product new molecular entities and existing commercial products to internal Lilly sites or external contract manufacturers.
- Serve as manufacturing technology transfer lead for transfers to Lilly sites and/or CMOs.
- Provide strategic oversight from late-stage development through process validation and launch readiness (alignment with global manufacturing, regulatory, and quality strategies).
- Drive process validation strategy, design, execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decisions.
- Author/co-author technology transfer documents and contribute to regulatory submission sections (CMC).
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners for process alignment/consistency.
- Develop and align manufacturing control strategies with development, Global Molecule Stewards, and Global Platform Stewards.
- Own technical interface between technology transfer and CMC teams; align control strategy, process design, and submission readiness.
- Present technology transfer status, risks, and 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/Skills
- 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 leveraging digital tools to improve collaboration/efficiency.
- Track record of operational excellence via process improvement/standardization/lean.
- Experience implementing/improving teamwork and knowledge management processes.
Education
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
Other
- Travel required (domestic and international) up to 25%.
Benefits
- Eligibility for company bonus (based on company/individual performance).
- Comprehensive benefit program: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits (e.g., healthcare/dependent day care FSA), life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., employee assistance program, fitness, employee clubs/activities).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
- Lead technical activities during technology transfers of parenteral drug product new molecular entities and existing commercial products to internal Lilly sites or external contract manufacturers.
- Serve as manufacturing technology transfer lead for transfers to Lilly sites and/or CMOs.
- Provide strategic oversight from late-stage development through process validation and launch readiness (alignment with global manufacturing, regulatory, and quality strategies).
- Drive process validation strategy, design, execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decisions.
- Author/co-author technology transfer documents and contribute to regulatory submission sections (CMC).
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners for process alignment/consistency.
- Develop and align manufacturing control strategies with development, Global Molecule Stewards, and Global Platform Stewards.
- Own technical interface between technology transfer and CMC teams; align control strategy, process design, and submission readiness.
- Present technology transfer status, risks, and 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/Skills
- 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 leveraging digital tools to improve collaboration/efficiency.
- Track record of operational excellence via process improvement/standardization/lean.
- Experience implementing/improving teamwork and knowledge management processes.
Education
- BS, MS, or PhD in chemistry, pharmacy, engineering, or related scientific discipline.
Other
- Travel required (domestic and international) up to 25%.
Benefits
- Eligibility for company bonus (based on company/individual performance).
- Comprehensive benefit program: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits (e.g., healthcare/dependent day care FSA), life insurance/death benefits, time off/leave benefits, and well-being benefits (e.g., employee assistance program, fitness, employee clubs/activities).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation