Technical Transfer Lead
Elanco
Summary
The Technical Transfer Lead plays a central leadership role during the development of pharmaceutical, biopharmaceutical, and vaccine products for farm animal and pet health. This strategic role is responsible for orchestrating complex transfer activities from development labs to both internal and external manufacturing sites globally. You will serve as the critical technical bridge between Global Technical Development (GTD) and Manufacturing & Quality (M&Q), navigating friction points and balancing technical innovation with supply chain requirements. This role requires the ability to lead high-performing cross-functional teams without a direct reporting line to deliver project milestones on time and within budget.
Job description
Key Responsibilities
Leadership & Strategic Influence
- Lead without Authority: Direct the Process Transfer Team, including representatives from GTD, M&Q, Regulatory CMC, and external partners.
- Cross-Functional Liaison: Effectively navigate the interface between R&D and Manufacturing, managing the needs and deliverables of both organizations.
- Innovation Culture: Foster a culture of high-level problem solving and technical cooperation between global subject matter experts.
- Stakeholder Management: Communicate technical risks and progress to global line function heads and escalate critical issues to senior leadership.
- Global Integration: Involve and align global functions including TSMS, Engineering, HSE, Supply Chain, and Quality Assurance.
Technical Expertise & Execution
- Transfer Planning: Develop and own the Process Transfer Plan, including comprehensive gap/risk assessments and the establishment of technical acceptance and closing criteria.
- Compliance: Ensure all relevant quality and global regulatory (CMC) requirements are implemented using a risk-based approach.
- Technical Oversight: Manage technical functions to ensure objectives are met in a high-quality, cost-effective manner, including proactive contingency planning.
- Final Delivery: Oversee the successful completion and approval of the Process Transfer Report.
Project Management & Operations
- Operational Excellence: Lead the assembly and kick-off of the Process Transfer Team, ensuring clear roles and responsibilities.
- Resource Forecasting: Provide critical data to facilitate accurate project budget forecasts and technical resourcing.
- Milestone Monitoring: Generate and maintain the master project plan, monitoring major technical milestones and timelines.
- Site Coordination: Facilitate seamless communication and data transfer between the Transferring Site and Receiving Site (internal or external).
Minimum Qualifications
- Education: BS, MS, or PhD in a related scientific field (Pharmacy, Chemistry, Biology, or Engineering).
- Experience: Minimum of 10 years of relevant experience in analytical, process, or packaging development.
- Technical Background: Demonstrated technical expertise in both Development and Manufacturing environments.
- Product Knowledge: Deep scientific knowledge in either Biopharmaceuticals/Vaccines or Small Molecule/Pharmaceuticals.
- Regulatory Familiarity: Solid understanding of global regulatory (CMC) requirements for veterinary pharmaceutical products.
- Language: Excellent written and oral English communication skills.
Additional Skills/Preferences
- External Partnering: Proven experience working with Contract Development Manufacturing Organizations (CDMOs) is highly preferred.
- Problem Solving: A proactive, solutions-oriented mindset with a focus on continuous improvement of transfer methodologies.
- Influence: Strong interpersonal skills with a proven track record of influencing stakeholders across different departments.
- Systems Literacy: Proficiency in MS Project and standard MS Office applications.
Other Information
- Travel: Requires global travel to manufacturing sites (approx. 10–15%).
- Location: Indianapolis, IN.
Requirements
- BS, MS, or PhD in a related scientific field (Pharmacy, Chemistry, Biology, or Engineering)
- Minimum of 10 years of relevant experience in analytical, process, or packaging development
- Demonstrated technical expertise in both Development and Manufacturing environments
- Deep scientific knowledge in either Biopharmaceuticals/Vaccines or Small Molecule/Pharmaceuticals
- Solid understanding of global regulatory (CMC) requirements for veterinary pharmaceutical products
- Excellent written and oral English communication skills
- Proven experience working with Contract Development Manufacturing Organizations (CDMOs) is highly preferred
- A proactive, solutions-oriented mindset with a focus on continuous improvement of transfer methodologies
- Strong interpersonal skills with a proven track record of influencing stakeholders across different departments
- Proficiency in MS Project and standard MS Office applications
Benefits
- Relocation packages
- Two weeklong shutdowns
- Parental leave
- Employee resource groups
- Annual bonus
- Flexible work arrangements
- 401(k) matching
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.