Parenteral Commercialization Technology Transfer Lead
About The Position
The Parenteral Commercialization Technology Transfer Lead is responsible for technical leadership during technology transfers of parenteral drug product new molecular entities and existing commercial products to internal Lilly sites or external contract manufacturers. This role interacts and partners with numerous functions, including development, engineering, regulatory, and quality, to design and oversee execution of the technology transfer plan, studies, and other supporting activities. Additionally, this role works closely with the Global Commercialization Steward and Global Molecule Stewards to ensure alignment in commercialization practices and study designs to support successful product transfer. The Commercialization Technology Transfer Lead must have strong interpersonal and communication skills. A person in this position has previous experience in the commercialization of parenteral products and is expected to adhere to required technology transfer guidance and requirements. This position is an individual contributor in a scientific track.
Requirements
- BS, MS, or PhD in chemistry, pharmacy, engineering, or other related scientific discipline.
- Manufacturing experience in the commercialization and technology transfer of parenteral and/or device combination products.
- Manufacturing experience supporting commercial manufacturing.
- Excellent written and oral communication skills.
- Understanding of cGMP’s, policies, procedures, and guidelines.
- Demonstrated technical leadership of cross-functional teams.
- Technical knowledge of parenteral products and control strategies.
- Strong interpersonal and teamwork skills.
- Strong self-management and organizational skills.
Nice To Haves
- Prior 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 and/or CBE, site transfers).
- Experience with data analytics, visualization, and/or AI tools. Comfort leveraging digital tools and platforms to improve team collaboration and efficiency.
- Track record of driving operational excellence through process improvement, standardization, or lean methodologies.
- Experience implementing or improving teamwork processes and knowledge management processes.
Responsibilities
- Serve as manufacturing technology transfer lead for the 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, ensuring alignment with global manufacturing, regulatory, and quality strategies.
- Drive process validation strategy, design, and execution, and successful handoff to commercial manufacturing for new molecule technology transfers.
- Own technical assessments (e.g., process risk assessments, gap assessments) and drive real-time technical decision-making throughout the technology transfer lifecycle.
- Author/co-author technology transfer documents associated with the transfer of new molecules and commercial manufacturing sections of regulatory submissions.
- Coordinate technology transfer activities across multiple receiving sites and/or external manufacturing partners, ensuring process alignment and consistency across the parenteral network.
- Partner with development, Global Molecule Stewards, and Global Platform Stewards to develop manufacturing control strategies to ensure seamless scale-up and commercial readiness across global manufacturing sites.
- Own the technical interface between the technology transfer team and CMC team, driving alignment on control strategy, process design, and submission readiness in collaboration with Global Molecule Stewards.
- Present on technology transfer status, risks, and technical decisions at program 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.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
