Director of Analytical Methods Development

The Director of Analytical Methods Development in the Therapeutics Production & Quality Department manages activities related to the research and development of analytical methods to support the characterization and release testing of biotherapeutics produced under Current Good Manufacturing Process (cGMP) for Phase I and Phase II human clinical trials. Works closely with the Process Research and Development and the Quality Control groups. Uses knowledge and understanding of the regulations governing the analytical testing and characterization of biopharmaceuticals as mandated by the United States Food and Drug Administration (FDA), European Medicines Agency (EMEA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Uses Quality by Design (QbD), as recently adopted by the FDA as a vehicle for the research and development of analytical methods for biopharmaceutical. Trains and delegates report writing to staff. Reviews and approves all method development reports and technical transfer of methods to Quality Control. Maintains proper documentation and report writing as related to analytical research and development. Works with the TPQ Director of Project Management to establish method development project time lines. Reviews data, accesses issues and devise strategies to solve problems. Manages and communicates effectively to the process development staff the goals and objective of a project. (MJP)