This newly created position of Director/Sr. Director Analytical Methods Development reports to the VP Process and Manufacturing Sciences and will manage all analytical activities involving product and process characterization, comparability studies and the development of analytical methods in support of biologics process development and manufacturing. The candidate should have deep technical experience in the development of chromatographic-based, mass spec-based, and Elisa-based methods. The ideal candidate will have experience in the development of analytical methods for antibody-drug-conjugates. The position includes supervising a group of scientists and associates in the characterization and comparability of biologics and the development of analytical methods and the transfer of these methods to Quality Control in support of cGMP manufacturing activities.
Direct oversight of all analytical methods development activities.
Lead the development and qualification of chromatographic assays (HPLC, LC-MS/MS), Immunoassays (impurity ELISAs, Western-blot) and electrophoretic assays (SDS-PAGE, IEF, CE) for product and process characterization and QC release of our antibodies and ADCs.
In-depth characterization of our antibody-based drug products that are in clinical and commercial development.
Develop and manage comparability programs to support regulatory filings for process changes.
Evaluate and recommend the purchase of analytical instrumentation including new technologies useful to IMMU’s future drug development efforts.
Preparation of analytical data, reports, and CMC documents required for various regulatory authorities.
Provide mentoring for associate scientists.
Provide organizational leadership in all areas related to analytical methods development.
Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals.
Manage the department budget consistent with organization and corporate goals.
Assign resources according to priority and project needs.
Through the development of methods and analysis of product quality results, support continuous process improvement efforts.
Provide data and metrics across the department and to senior management on a regular basis.
PhD in the biology or chemistry-related disciplines and 10+ years industry experience in a GMP environment.
Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products, preferably including antibody drug conjugates.
Strong familiarity of the collection of analytical techniques.
Fluent in the regulatory guidance documents that touch upon biologics drug development.
Solid understanding of cGMPs and compliance requirements.
Prior experience interacting with the FDA during pre-approval inspections or semi-annual commercial manufacturing inspections.