Director of Upstream Process Characterization and Validation
Adagio is seeking a motivated, dynamic contributor to help build and lead a cell culture process development and process characterization function in a science-driven and collaborative environment in support of the development of a late-stage biologic drug candidate. The ideal candidate will have a background with extensive hands-on process development and experience reviewing and organizing analytical data as well as proficiency in the ability to manage activities and solve development challenges at third party pharmaceutical manufacturers. The position requires a strong background in process characterization and a thorough knowledge of cGMPs ICH and relevant FDA guidelines. She/he will facilitate the creation of fundamental product and process understanding to facilitate the advancement of drug development program. Extensive late-stage experience is preferred.
Summary of Key Responsibilities:
- Provide technical leadership for external late-stage clinical process development, characterization and technology transfer, validation with line-of -sight for commercialization.
- Oversight of experimental design, and compilation and interpretation of associated data packages.
- Develop and ensure the delivery of high-quality documentation to meet global regulatory expectations for analytical methods and controls. Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
- Support relevant vendors (CMOs) during the development and characterization of the drug substance manufacturing process. Travel to CMOs as needed (when safe and appropriate).
- Identify staffing needs and recruits/hires/promotes personnel as appropriate.
- Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
The successful candidate has a broad understanding of cell culture and regulatory/GMP requirements, and a proven track record in process development for different clinical stage programs. Excellent communication and collaboration skills in a cross-functional and fast-paced environment as well as a proven ability to achieve results with external laboratories and manufacturing facilities are a must. Other requirements include:
- Demonstrated and significant experience with protein-based biologics process development in support of clinical and commercial programs, preferably monoclonal antibodies. Preference given to candidates with late clinical stage development experience.
- Experience with statistical process control and/or multivariate statistical data analysis
- Experience with the preparation of regulatory filings
- Related experience with purification development is a plus
- Advanced degree in Biochemistry or related field, PhD preferred but not required
- 10+ years of relevant analytical experience for biologics in the pharmaceutical industry
- Remote work location. While geography is not important, the Head must be typically available during normal Eastern US time zone working hours. Some conference calls outside of work hours is expected.