Vacancy caducado!
Senior Scientist About Company: A global biopharmaceutical company, that is focused on discovering and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. The company is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates. Position Overview: Looking for a Process Development subject matter expert to supplement its internal and external teams. The ideal candidate for this position will be responsible for planning and execution of process development activities across the portfolio of viral vaccine products. Essential Duties:
- 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