Technical Transfer Lead

Indiana Ag Connection

Indianapolis, Northern (IN, KY)

Hybrid

USD 140,000 - 210,000

Full time

9 days ago
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Benefits offered by this job

Relocation packages
Two weeklong shutdowns in the US
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching

Job summary

Elanco is seeking a Technical Transfer Lead to orchestrate cross-functional transfer of pharmaceutical products from development to manufacturing at global sites. The role requires leading teams across GTD, M&Q, and external partners, guiding planning, risk assessment, and regulatory compliance.

Ideal candidates have 10+ years in analytical, process, or manufacturing roles with deep knowledge in biopharma or small molecules, and strong English communication skills.

Qualifications

  • Minimum of 10 years of relevant experience in analytical, process, or manufacturing development.
  • Deep knowledge in Biopharmaceuticals/Vaccines or Small Molecule/Pharmaceuticals.
  • Solid understanding of global regulatory (CMC) requirements for veterinary products.
  • Excellent written and oral English communication skills.

Responsibilities

  • Lead the Process Transfer Team and coordinate with GTD, M&Q, Regulatory CMC, and external partners.
  • Oversee transfer planning, risk assessments, and technical acceptance criteria.
  • Ensure compliance with quality and regulatory requirements in a global context.
  • Drive project milestones, budgets, and timelines with cross-functional teams.

Skills

Leadership
Cross-functional collaboration
Strategic influence
Project management

Education

BS/MS/PhD in related field

Tools

MS Project
MS Office

Job description

# Technical Transfer LeadBack to search resultsApply to this positionFollow CompanyMore Jobs from ElancoSend to Friend**At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals' lives better makes life better - join our team today!** **Job Description** 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 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. 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 Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job - related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice. #LI-MW1
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