Scientist, Process Development

Process Development Seattle, Washington


Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics.  Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.

About the Position

 Zymeworks is currently seeking a Scientist/Senior Scientist, Process Development, to join our process development group within Technical and Manufacturing Operations. The successful candidate will be responsible for overseeing an upstream phase I process development campaign from cell line development to tech transfer to manufacturing.  The candidate will manage external CDMO partners in the planning and execution of bench scale studies and associated technical transfer activities.  The successful candidate will have a background in cell line and upstream process development, working knowledge of regulatory requirements for an IND filing, and a demonstrated ability to establish and maintain positive working relationships. 

The Scientist/Senior Scientist, Process Development will be based in Seattle, WA. 

Key Responsibilities:

  • Lead early-stage cell line, process development, and tech transfer to support IND.
  • Collaborate with external partners to plan, review, approve, monitor, and analyze bench scale process development experiments and investigations.
  • Review and approve technical documents including scopes of work, development plans, summary reports, and technical transfer documents, and master batch records.
  • Organize and maintain internal archive of raw data and reports generated by CDMO partners.
  • Author relevant sections of regulatory filings, including IND.
  • Communicate progress and findings with internal partners including manufacturing and technical operations, project management, regulatory and quality groups.
  • Provide technical support for manufacturing operations and technology transfer.
  • Establish and maintain positive working relationships with peers, management and external partners.

Education and Experience:

  • University degree and a minimum of 5 years related experience with at least 3 years in upstream process development or equivalent combination of education and experience.

Skills and Abilities:

  • Experience directly working in at least two (2) of the following areas: mammalian cell line development, upstream process development, and/or tech transfer to manufacturing in a GxP environment.
  • Direct experience with bioreactors operation.
  • Working knowledge of statistical methods and design for screening and optimization.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Solid technical writing skills, including knowledge of expected content.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

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