PROCESS DEVELOPMENT MANAGER (closed)
PROCESS DEVELOPMENT MANAGER
Simply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a Process Development Manager for a leading and growing San Diego biotech firm.
The qualified Process Development Manager will be responsible for developing and implementing improvements to the current manufacturing process and production capabilities for plasmid DNA, identifying and resolving production problems quickly, and leading the design and execution of scale-down qualifications, pCPP risk assessments, process characterization studies, and impurity clearance validations. The Process Development Manager will work with Manufacturing, Engineering, QC, QA, and other departments to author and/or review process validation protocols and reports, assist with implementing CAPAs, and identify opportunities to streamline manufacturing operations, increase efficiency, and reduce costs. This person will supervise and mentor Process Development engineers and scientists and provide technical guidance to Manufacturing engineers.
The qualified Process Development Manager will possess the following:
* Ph.D. degree in Chemical or Biochemical Engineering
* 5-10+ years experience in a process development function in the biopharmaceuticals industry
* Broad experience in the development of production processes for biologics, including experience with fermentation or cell culture, cell lysis, precipitation, and chromatography
* Experience applying QbD principles to biologics process characterization and validation
* Ability to conduct process failure investigations and resolve production problems quickly
* Experience working in a cGMP environment, including familiarity with cGMP documentation practices and investigating process deviations
* Track record of developing and implementing improvements to clinical and/or commercial manufacturing processes
* Experience supervising and motivating Bachelor- and Masters-level scientists and engineers
* Ability to communicate clearly and precisely, both orally and in writing
* Ability to work with diverse group of people, effectively balance competing priorities, and meet tight timelines.