Head of Analytical Development, Biopharma Full Time

At Elanco (NYCE: 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!

Position Description

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 15+ years of overall industry experience, at least 7+ years of which working in analytical development of monoclonal Antibodies and therapeutic proteins

Additional Preferences

• 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)

Other information

• 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

Alternatively, you can view other roles for reentry opportunities at https://reentrycareers.com/

Tagged as: Freelance