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Process Development Associate

San Mateo Metro Area, CA

Posted: 10/30/2018 Job Number: JN -102018-22940

The candidate would especially be involved in carrying downstream applications, such as preparing crude viral lysate for purification, independently purifying virus according to established methods and contributing to the development of novel purification techniques. The successful candidate should also be enthusiastic about contributing to the dynamic directed evolution platform.

Essential duties and responsibilities include but are not limited to the following:

  • Help with manufacturing of AAV through the downstream purification process (cell lysate to final formulation)
  • Streamline current processes
  • Work hands-on to develop, optimize, and scale-up downstream processes for the purification of AAV vectors from small to large scale purification systems in a laboratory setting
  • 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 according to corporate timelines in order to advance the product pipeline.
  • Ensure a safe work place in compliance with the company and EH&S' 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 fields
  • Gene therapy viral vector production experience is required
  • Expertise in AAV or other gene therapy vector expression in mammalian cells via transient transfection is a plus
  • Hands-on experience with density-gradient ultracentrifugation is highly desirable
  • Experience with protein purification including hands on experience with TFF (Hollow Fiber / Cassettes) UF/DF, GE AKTA (Avant, Pilot), chromatography at small/pilot/large scale is a plus
  • Proficiency in general molecular biology techniques including ELISA, qPCR, BCA
  • Western Blot and Silver Stain experience is preferred but not required
  • Experience drafting SOPs, Batch records, reports, and protocols is preferred
  • Highly motivated team player capable of leading by example and who exceeds expectations in all aspects of the role
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