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.
Key ResponsibilitiesLeadership & 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.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
