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Upstream Process Development Associate

San Mateo Metro Area, CA

Post Date: 01/16/2017 Job ID: JN -012017-18132
Process Development team is looking to bring on board an Upstream Process Development Engineer to help support the continued development, manufacturing and commercialization of our AAV vectors for our therapies that address both our rare diseases programs as well as our Ophthalmology programs.

POSITION REQUIREMENTS AND EXPERIENCE:

  • Ph.D., with 0-2 years of experience, MS with 2-4 years of experience BS with 4+ 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.

RESPONSIBILITIES:

  • 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

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