Parenteral Commercialization Technology Transfer Lead

Lilly•Indianapolis, IN

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Brand Description: 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.
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals.

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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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