Director, Analytical Development

Catalent Pharma Solutions Inc   •  

Madison, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 30 days ago

Position Summary

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our state-of-the-art biomanufacturing facility in Madison, WI, our Drug Product and Drug Substance facility in Bloomington Indiana, our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Role

  • The position is expected to direct the analytical development group in all aspects of biologics development. This includes method transfer and development, preliminary formulation development and protein characterization using biophysical methods and Mass Spectroscopy. It is expected that the position will act as a site SME to support our client’s analytical needs as well as identify methods and equipment that can further support our clients.
  • The Director is expected to use their wide range of analytical expertise to develop the activities of the Analytical Group.
  • The Director requires strong management and technical skills to support the day to day activities of the group, act as a technical expert both to internal groups as well as to clients and use their troubleshooting expertise to overcome technical issues with novel molecules.
  • The Director is responsible for the expansion of the analytical capabilities of the group by sourcing, coordinating and implementing the equipment and methods required to support extensive process and product characterization activities

The Candidate

  • BS in Biochemistry, Analytical Chemistry or other relevant discipline with 10+ years of experience working in the biotechnology industry.
  • The Director is expected to have a wide range of technical experience in techniques including, but not limited to HPLC (SEC, RP, HIC, IEX, peptide mapping, glycan profiling) with variety of detection modes (UV, PDA, FLR, MALS, etc.), capillary (cIEF, CE, LabChip) and gel electrophoresis, ELISA for potency and residuals, etc.
  • The Director is expected to have a good understanding of the characterization of biologics and to provide technical advice to our clients.
  • The ability to successfully lead multiple projects to their completion, as well as the ability to write plans, protocols, reports, business correspondence, and procedures.
  • Ability to manage several diverse projects simultaneously, with consideration to resource loads and personnel management.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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