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Associate Director/Sr. Scientist, Upstream Process Development

  • Location: South San Francisco
  • £ Salary: Negotiable per year
  • Job Type:Permanent

Posted over 1 year ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 28 October 2022
  • Job Ref: JN -092022-474172

Associate Director/Sr. Scientist, Upstream Process Development

SSF, CA

We are looking for an Associate Director/Sr. Scientist, Upstream Process Development who will help develop processes using our novel protein synthesis process to manufacture protein biotherapeutics. The individual will participate in cross-functional teams and collaborate on multiple projects to support development of product candidates in various stages from lead optimization, GMP manufacturing, as well as late-stage development toward commercialization. Responsibilities include working with multiple groups in R&D to improve product titers and product quality by examining the biochemical and physical factors affecting cell-free performance and scale-up. This role will also be involved in process transfers to internal and/or external manufacturing facilities, providing technical support during GMP productions (PIP, change control, deviations, CAPA, etc.), and supporting regulatory filings. Further duties may include development and qualification of scale-down models and conducting process characterization/process validation studies for late-stage programs. This position will also collaborate with the Platform Technology R&D group to further performance and understanding of our technology.

Responsibilities:

The successful candidate will work with the Upstream PD Pipeline team to design and execute cell-free protein synthesis experiments and develop new methods/techniques as needed. Work will focus on late-stage development (Phase 2 and later) of existing programs and also assist with early stage (pre-GMP and FIH production) for new programs. This position will interface with manufacturing sites (internal and/or external) to transfer new/improved processes and ensure consistent process performance. In addition, the successful candidate will be required to make presentations to internal teams and senior management and to author internal and external publications including contributions to regulatory submissions as needed.

Qualifications:

We are seeking a highly motivated team-player with excellent problem-solving skills and experience with bioprocesses and microbial metabolism. Versatility is a must, as tasks will involve a range of reactors and scales and process modes. Good organizational skills and the ability to manage tasks within a timeline are essential.

The ideal candidate will have the following background/skill set:

  • PhD with 7 or more years or BS/MS with 12 or more years of industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related discipline
  • Experience with the following is required:
  • laboratory scale process equipment, especially bioreactors for microbial and/or mammalian culture
  • bioprocess development for therapeutics (cell-free, microbial, and/or mammalian cell-based)
  • process transfer to GMP manufacturing or support of existing GMP processes
  • Experience with the following is preferred:
  • late-stage upstream process development (Process Characterization/Process Validation)
  • scale-up to > 1000L bioreactor scale
  • scale-down model development and qualification
  • authoring regulatory documents (IND/BLA sections, responses to agency questions, etc.)
  • Design of Experiments, statistical analysis, MVA
  • cell-free protein synthesis
  • metabolite/biochemical assays (HPLC and/or microtiter plate based)

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