As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Head of Analytical Development Biopharma is responsible for the technical and strategic leadership of analytical scientists supporting Elanco’s Biopharma R&D portfolio. The team develops, validates, verifies and transfers a wide range of analytical methods (e.g. immunoassays, chromatographic, electrophoretic, LC/MS, compendial) for research and development-stage biopharmaceutical products (mAbs, fusion proteins, therapeutic vaccines). The incumbent will partner and collaborate with other internal Technical Development functions (Upstream and Downstream process development, formulation development), as well as with scientists and project managers at CDMOs who are entrusted with method development & validation. Other Elanco internal collaboration interfaces are Quality, Regulatory, Research, Product Development, HSE, TS/MS, Reference Standard and Manufacturing functions. The Head of Analytical Development must have an excellent understanding of control strategies and bring several years of experience in development and validation of analytical methods for mAbs and therapeutic proteins, preferably in the Animal Health industry. Key success factors for this role are to guide and oversee the development and validation/transfer of robust analytical methods, establishment of control strategies and issuance of regulatory documents as well as coaching, development and leadership of senior analytical scientist.
Functions, Duties, Tasks
- Overall accountability of Biopharma Technical Development’s analytical deliverables e.g. methods, validations, transfers, clinical material release testing and regulatory documents
- Lead a team of senior analytical scientists and provide technical and strategic guidance &
- direction; help serving as an interface to external CDMO partners
- Ensure delivery of the analytical CMC package for biopharma product submissions; experience with preparation of documentation for regulatory submission and a deep understanding of the memoranda
- Provide technical leadership and coaching to ensure timely and successful delivery of project outcomes in accordance with key project milestones (e.g. methods, validations, CT release testing)
- Manages and prioritizes analytical resources in alignment with other internal and external functions to deliver against timelines and budgets
- Implement and develop technical and professional capabilities to keep the analytical team abreast of portfolio needs and industry trends, as well as balancing and optimizing analytical work conducted internally and externally at CDMOs
- Enable compliance with quality, regulatory, safety, and performance standards
- Create and sustain a culture of high technical rigor and innovation
- Develop personnel, manage and retain key talent, and effectively recruit to fill capability gaps.
- Facilitate efficient knowledge sharing across technical teams (Research, Development, TSMS) to ensure robust problem solving · Build, leverage and optimize tools, systems, and business process to enable efficiency, effectiveness, and quality in Tech Dev
- Serve as a key member of the Biopharma Technical Development Lead Team
Minimum Qualification (education, experience and/or training, required certifications)
- Ph.D. in biochemistry or related field with at least 17 years of overall industry experience, at least 12 of which working in analytical development of monoclonal Antibodies and therapeutic proteins
- Strongly desired to have some Animal Health industry experience
- Experience with establishing Analytical Control Strategies for Biologics
- Experience with applicable regulatory agencies (FDA, USDA, EMA)
- Experience with quality standards (e.g. GMP)
- Travel ~10%; role will be located in Elanco Global HQs (Indiana, US)
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