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Manufacturing Associate II

San Mateo Metro Area, CA

Posted: 05/01/2018 Job Number: JN -052018-21477

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

RESPONSIBILITIES:

  • 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.
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