Manufacturing Associate II
San Mateo Metro Area, CA
Downstream Manufacturing Associate II
Our highly skilled and talented Process Development team is looking to bring onboard a Downstream Manufacturing Associate II to help support the continued development, manufacturing and commercialization of our vectors
- Help with manufacturing of viruses through the downstream purification process (post cell lysate to final formulation)
- Optimize, revise, and update current processes to make them more robust and streamlined
- Pursue work with the goal of improving the existing virus purification process, optimizing, revising, and updated for robustness and efficiency / streamline.
- Work hands-on to develop, optimize, and scale-up downstream processes from small to large scale purification systems in the laboratory setting for the purification of AAV vectors.
- 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.
- Interact with Assay Development, QC, QA, and pre-clinical group.
- Develop novel AAV manufacturing processes with the highest quality on time to advance product pipeline.
- Ensure safe work place in compliance with the company and EHS rules and regulations.
- Keep current with advances in downstream processes for viral vector production.
POSITION REQUIREMENTS AND EXPERIENCE:
- MS with 2-4 years of experience or BS with 4+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields.
- Hands on experience with TFF (Hollow Fiber / Cassettes) UD/DF, GE AKTA (Avant, Pilot), chromatography at small/pilot/large scale is required.
- Proficient in theory of chromatography and protein purification.
- Proficient in general molecular biology techniques including ELISA, qPCR, BCA.
- Experience drafting SOPs, Batch records, reports, and protocols is required.
- Broad experience in cGMP biologics manufacturing and documentation required, with additional understanding of regulatory guidelines preferred.
- Highly motivated team player capable of leading by example and who exceeds expectations in all aspects of the role.
- Hands-on experience in the insect cell-baculovirus expression technology platform is a plus.