Parenteral Commercialization Technology Transfer Lead

Parenteral Commercialization Technology Transfer Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

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%).

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 for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $102,000 - $209,000.

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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.