Parenteral Commercialization Technology Transfer Lead
Eli Lilly and Company
2 months ago
On-site
Indianapolis, IN
Operations
Position: Parenteral Commercialization Technology Transfer Lead (Scientific individual contributor)
Responsibilities:
- Serve as manufacturing technology transfer lead for transferring 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, execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decision-making across the technology transfer lifecycle.
- Author/co-author technology transfer documents and commercial manufacturing sections for regulatory submissions.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure process alignment.
- 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 to align 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.
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.
- 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 skills.
- Strong 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/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.
- Track record driving operational excellence via process improvement/standardization/lean methodologies.
- Experience implementing/improving teamwork and knowledge management processes.
Education requirement:
- BS, MS, or PhD in chemistry, pharmacy, engineering, or other related scientific discipline.
Other:
- Some travel (domestic and international) required (up to 25%).
Benefits (explicitly stated):
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits including company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription drug; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance/death benefits; time off and leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (explicitly stated):
- Anticipated wage: $102,000–$209,000.
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 transferring 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, execution, and handoff to commercial manufacturing.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decision-making across the technology transfer lifecycle.
- Author/co-author technology transfer documents and commercial manufacturing sections for regulatory submissions.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners to ensure process alignment.
- 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 to align 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.
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.
- 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 skills.
- Strong 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/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.
- Track record driving operational excellence via process improvement/standardization/lean methodologies.
- Experience implementing/improving teamwork and knowledge management processes.
Education requirement:
- BS, MS, or PhD in chemistry, pharmacy, engineering, or other related scientific discipline.
Other:
- Some travel (domestic and international) required (up to 25%).
Benefits (explicitly stated):
- Eligibility for a company bonus (depending on company and individual performance).
- Comprehensive benefits including company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription drug; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance/death benefits; time off and leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Compensation (explicitly stated):
- Anticipated wage: $102,000–$209,000.
Application instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation