Associate Director of Bioassay Development
Adagio is seeking a motivated, dynamic contributor with a strong scientific background in cell-based potency and immunoassay methods to lead bioassay development in the Technical Operations group. 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 experience in the development and qualification of cell-based functional potency assays for product release and characterization throughout clinical development and the ability to manage activities and solve development challenges at third party development and testing sites. The position requires a strong background in assay development and a thorough knowledge of cGMPs ICH and relevant FDA guidelines. Extensive late-stage clinical development experience is preferred.
Summary of Key Responsibilities:
- Lead bioassay method development, phase appropriate qualification/validation, and technology transfer, with all activities in accordance with ICH and FDA guidance and ensure that the method protocols, assay qualification and validation plans/reports adhere to GMP requirements and ICH guidelines.
- Work with CMOs/CROs to transfer, establish and support the potency methods for late-stage product release and stability testing
- Support the application of the potency methods for product characterization, comparability studies, and the establishment of process control strategies
- Work with colleagues in Virology and Pre-Clinical groups to develop methods reflective of mechanism of action. Work with Analytical Characterization to design and execute structure function relationships.
- 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/CROs). Travel 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.
Qualifications:The successful candidate has a broad understanding of bioassay development and regulatory/GMP requirements, and a proven track record in analytical 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 bioanalytical methods, such ELISA, cell-based reporter assays, antibody effector function assays and viral assays. Preference given to candidates with late clinical stage development experience.
- Experience with QbD principles and Design of Experiment approaches for method development/optimization. Experience with statistical approaches for assay development and related software.
- Experience with the preparation of regulatory filings
- Advanced degree in Biochemistry, Cell Biology, or related field, PhD preferred but not required
- 6+ years of relevant bioanalytical experience in the pharmaceutical industry
- Remote work location. While geography is not important, the candidate must be typically available during normal Eastern US time zone working hours. Some conference calls outside of work hours is expected.