AP Bioscience Direct Client is seeking an experienced scientist to join our Manufacturing and Process Development team and contribute to the development of our downstream Phase III and commercial viral vector manufacturing process. This individual will join a dynamic and motivated team to develop and characterize unit operations in support of a mid to late stage viral vector program, as well as tech transfer of the process to the clinical/commercial manufacturing team. The successful candidate will be responsible for design and execution of experiments supporting development, characterization, scale-up, and transfer of the downstream manufacturing processes. They will also be responsible for evaluation and implementation of new and existing technology. The candidate should be capable of working independently and within a multidisciplinary team.
- Development of scale-able and robust downstream processes
- Work independently to design and execute experiments related to development, optimization, scale-up, and characterization of all steps in a viral vector purification process
- Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
- Apply DOE and other advanced statistical techniques to design experiments related to process characterization and scale-up
- Design and execute viral clearance studies at contract testing labs
- Authoring of high quality documents, including technical reports, SOPs, and experimental protocols
- Maintain current lab environment (e.g. buffer/solution preparation, raw material ordering, equipment maintenance and repair, etc.)
- Ph.D. in Chemical Engineering or related field and 0-2 years of experience, Master degree or a Bachelor degree in the same field with 6+ years of experience in upstream process development
- Ability to manage, analyze, and interpret complex experimental data
- Ability to apply engineering fundamentals to process design and scale-up
- Ability to apply statistical tools for process monitoring, experimental design, and data analysis
- Have a working knowledge of purification instruments and their associated software (specifically GE Healthcare AKTA instruments and Unicorn software is a plus).
- Demonstrated ability in all modes of chromatography including column packing and buffer/solution preparation.
- Demonstrated ability in filtration principles and practice including general operation as well as capacity determination.
- Experience with virus inactivation and small virus retention filtration.
- Experience with continuous centrifugation and gradient ultracentrifugation
- Some travel may be required