Process Development Engineer II - Downstream

Menlo Park, CA 94025

Posted: 05/28/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 15796

Process Development Engineer II – Downstream

Menlo Park, CA (relocating to Redwood City in late 2019)

  • Work independently and with a team to manufacture AAV through the downstream purification process (post cell lysate to final formulation and final fill), purifying starting material from small shake flask to large bioreactor productions.
  • Independently develop and evaluate process changes and new technologies to optimize the existing downstream AAV process to enhance robustness, scale-ability, and/or yield.
  • Provide hands-on help and technical leadership in developing and qualifying scale-down / up models of the platform process.
  • Author and review technical documentation including batch records, Tech Transfer protocols, Campaign Summaries, and risk assessments.
  • Research and provide technical feedback during group discussions on downstream planning, processes, and projects.
  • Independently analyze and interpret data, draft technical summary reports, and present results to cross functional teams.
  • Perform molecular biology assays (ie: qPCR, silver stain, ELISA, HPLC, etc.) to support Process Development.
  • Follow GMP documentation to maintain accurate records through a highly organized lab notebook and data logging of process data.
  • Independently identify and solve complex technical problems of limited scope while providing solutions to management.
  • Search literature for methods, processes, and new technologies for downstream AAV process.
  • Emphasis of Quality Control, Quality Assurance, and Consistency throughout lab work performed.
  • Collaborate and interact with R&D, Assay Development, Quality, and Pre-Clinical groups to provide support on as-needed basis.
  • Ensure safe workplace in compliance with the company and EHS' rules and regulations.
  • Provide support for external manufacturing by reviewing and approving batch records, performing tech transfers, and providing technical support and PIP on as-needed basis,
  • Represent company to third parties (CMOs, vendors, collaborators, trade shows, training, etc.) in a professional manner.

  • MS with 2+ 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) UF/DF, and/or GE AKTA (Avant, Pilot), chromatography at small/pilot/large scale is required.
  • Additional experience with fill / finish is a plus.
  • Understanding of theory of chromatography, protein purification, and TFF.
  • Proficient in general molecular biology techniques and assays including qPCR, SS, ELISA, HPLC, and/or Mass Spectrometry.
  • Organized when juggling multiple projects at the same time and prioritizing own projects.
  • Experience drafting study plans, SOPs, Batch records, technical reports, and protocols and presentations on work performed is required.
  • Broad experience in cGMP biologics manufacturing and documentation required, with additional understanding of regulatory guidelines preferred.
  • Highly motivated team player capable of working with others in a fast pace environment.
  • Ability to use Microsoft Excel, Word, PowerPoint. Experimental design software, and statistical data analysis software a plus.
  • Hands-on experience in the insect cell-baculovirus expression technology platform is a plus.
  • Good to have – 5S or similar experience

Jesse Ashworth

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