Process Development Engineer III - Downstream

Menlo Park, CA 94025

Posted: 10/30/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16667

Process Development Engineer III - Downstream

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

 

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 final formulation,
  • 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 downstream 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 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.
  • 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 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 is required.
  • Proficient in general molecular biology techniques and assays including qPCR, SS, ELISA, HPLC, and/or Mass Spectrometry.
  • Must have excellent time management skills  and the ability  to multitaskprioritize 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.
  • Prior experience with insect cell-baculovirus expression technology and AAV gene therapy is a plus.
  • Some travel is required to qualify new vendors and oversee manufacturing activities.
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