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 analytical work conducted internally and externally at CDMOs; help serving as an interface to external CDMO partners

• Enable compliance with quality, regulatory, safety, and performance standards

• Create and sustain a culture of high technical rigor, innovation and engagement

• Develop personnel, manage and retain key talent, and effectively recruit to fill capability gaps; ability to fill in for temporary capability gaps through own competence & experience if needed

• 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

What You Need to Succeed (Minimum Qualifications):

• Education: Ph.D. in biochemistry or related field

• Experience: 15+ years of overall industry experience, at least 10 of which specifically working in analytical development of monoclonal Antibodies and therapeutic proteins

• Top 2 skills: Proven leadership with several years of direct supervisory experience in the biopharmaceutical industry. A strong, empathetic, and passionate leader who inspires teams and fosters a collaborative environment.

What Will Give You a Competitive Edge (Preferred Qualifications):

• 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)

Additional information

• Travel ~10%; Role will be located in Elanco Global HQs (Indiana, US)

Don’t meet every single requirement? Studies have shown underrecognized 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