Upstream Process Development Engineer I/II
San Mateo Metro Area, CA
POSITION REQUIREMENTS AND EXPERIENCE:
- MS with 0-2 years of experience
- BS with 2+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields
- Highly motivated team player capable of leading by example and who exceeds expectations in all aspects of the role
- Experience with Upstream Process Development, Cell Culture, scaling up, fermentation
- Hands-on experience in the insect cell-baculovirus expression technology platform at small/pilot/large scale is highly preferable.
- Expertise in bioreactor design/operation/validation and advanced statistics on PD and manufacturing data, application of metabolic engineering and working knowledge of molecular biology, biochemistry, and gene therapy is preferable.
- Broad experience in cGMP biologics manufacturing and understanding of regulatory guidelines is preferred
- Experience drafting SOPs, batch records, reports, and protocols is required.
- Independently design and execute experiments following appropriate laboratory procedures and produce competent and reproducible results to a high technical standard.
- Appropriately analyze data, interpret results, and maintain accurate records with minimum supervision.
- Support and manage CMO for clinical manufacturing Preparation of presentations and other materials, as needed, for internal and external meetings, regulatory filings, publications and grant applications
- Interact with Regulatory, QC, QA, contract manufacturers, and testing laboratories
- Ensure safe work place in compliance with the company s and EHS rules and regulations