Process Development Eng III

Adverum Biotechnologies in Menlo Park, CA

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • Compensation: $103,730.00 - 157,700.00 / Year*
position filled
RESPONSIBILITIES:
  • Independently design, develop, and evaluate process changes and new technologies to optimize the existing downstream AAV process to enhance robustness, scale-ability, and/or yield.
  • Technical lead and perform the development and qualification of scale-down / up models of the platform process.
  • Technical involvement in the planning and manufacturing of AAV based viral vectors for development use encompassing the entire process from thaw to harvest,
  • Author and review technical documentation including batch records, Tech Transfer protocols, Campaign Summaries, and risk assessments.
  • Lead and provide technical feedback during group discussions on upstream planning, processes, and projects to maintain timelines and managing project teams to meet goals.
  • Independently analyze and interpret data, draft technical summary reports, and present results to cross functional teams
  • Identify assays needed for in-process control to support Process Development.
  • Independently solves complex technical problems.
  • Follow good documentation practices 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 notifying management.
  • Search literature for methods, processes, and new technologies for upstream 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.
POSITION REQUIREMENTS AND EXPERIENCE:
  • MS with 4+ years of experience or BS with 6+ years of experience in Chemical Engineering, Biochemistry, Cell & Molecular Biology or related life science engineering fields.
  • Hands on experience with bioreactors at small/pilot/large scale is required.
  • Understanding of process scale-up or scale-down.
  • Proficient in general molecular biology techniques including ELISA, qPCR, BCA, Silver Stain/Western Blot.
  • Must have excellent time management skills and the ability to multitask/ prioritize work in order to support organizational needs, meet deadlines and timeframes.
  • Experience drafting, reviewing and following, SOPs, Batch records, technology transfer documents 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 working with others in a fast pace environment.
  • Ability to use Microsoft Excel, Word, PowerPoint. Experimental design software, and statistical data analysis software a required.
  • Previous experience in the insect cell-baculovirus expression technology platform is a plus.
  • Prior AAV gene therapy vector or other viral particle production experience is a plus.
  • Some travel is required to qualify new vendors and oversee manufacturing activities.

Associated topics: bio, bioengineering, biology, biomaterials, bioprocessing, biosynthetic, fermentation, genetic, pathogenesis, pharmaceutical

* Estimated salary


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