Sr. Director Analytical Development, Biopharma

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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

Your Role: Sr. Director Analytical Development, Biopharma

The Sr. Director Analytical Development, Biopharma is responsible for the technical and strategic leadership of analytical scientists supporting Elanco’s Biopharma R&D portfolio. The Analytical 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 proteins).

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 internal QC labs and C(D)MOs who are entrusted with method transfer & validation. Other Elanco internal collaboration interfaces are Quality, Regulatory, Research, Product Development, HSE, TS/MS, Reference Standard and Manufacturing functions.

The Sr. Director Development must have an excellent understanding of control strategies and bring significant experience in development and validation of analytical methods for mAbs and therapeutic proteins, preferably in the Animal Health industry. Operationally, key success factors for this role are to guide and oversee the stage-appropriate development and validation/transfer of robust analytical methods, establishment of control strategies and issuance of regulatory documents. Strategically, key success factors are coaching and leadership of senior analytical scientists, building and expanding analytical capabilities and establishing a highly engaged team. 

Your Responsibilities:

• Overall accountability of Biopharma Technical Development’s analytical deliverables e.g. methods, validations, specifications, transfers, clinical material release testing and regulatory documents 

• Lead a team of senior analytical scientists and analytical leaders, and provide technical and strategic guidance & direction 

• 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) 

• Ensure delivery of the analytical CMC package for biopharma product submissions; experience with preparation of documentation for regulatory submissions and a deep understanding of guidelines, regulations & memoranda 

• 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