Descrizione dell'offerta
Parenteral Commercialization Technology Transfer Lead – responsibilities include leading technology transfers of parenteral drug product new molecular entities and existing commercial products to internal Lilly sites or external contract manufacturers. The role interacts with development, engineering, regulatory, and quality teams to design and oversee execution of technology transfer plans, studies and supporting activities.
Key Objectives/Deliverables
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.
Basic 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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals.
Additional Preferences
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.
Education Requirements BS, MS, or PhD in chemistry, pharmacy, engineering, or other related scientific discipline.
Other Information Some travel (domestic and international) required (up to 25%).
Compensation Annual salary range: $102,000 - $209,000.
Full‑time employees also eligible for a company bonus and comprehensive benefits including 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, and well‑being programs.
Accommodation Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Key Objectives/Deliverables
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.
Basic 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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals.
Additional Preferences
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.
Education Requirements BS, MS, or PhD in chemistry, pharmacy, engineering, or other related scientific discipline.
Other Information Some travel (domestic and international) required (up to 25%).
Compensation Annual salary range: $102,000 - $209,000.
Full‑time employees also eligible for a company bonus and comprehensive benefits including 401(k), pension, vacation benefits, medical, dental, vision, prescription drug benefits, flexible benefits, life insurance, and well‑being programs.
Accommodation Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
#J-18808-Ljbffr
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