Vacancy expired!
- Develop and transfer bioprocesses including USP, DSP, and formulation in a compliant manner, with statistically solid data and documentation.
- Design, lead, and perform experiments to generated developmental data and materials for studies.
- Responsible for preparation and review of technical documents, reports, publications, and oral presentations
- Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
- Support process equipment selection, FAT, SAT, and on-site qualification activities
- Provide guidance and training to associates across sites and functions as relates to assigned projects and consistent with the quality governance
- Represent the CMC Development function in project team meetings
- Bachelor's in biochemistry, chemical engineering, microbiology, biotechnology or related discipline with five years of experience in the biotechnology industry; or Masters/PhD with three years of experience in the biotechnology industry or equivalent work experience required
- Experience with mammalian cell culture, cell separation techniques. Viral purification experience such as Tangential Flow Filtration (TFF) or chromatography is a plus.
- Experience with cGMP manufacturing and regulatory submissions preferred
Vacancy expired!