Associate Director, Process Development

Process Development Seattle, Washington


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  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.

Zymeworks is currently seeking an Associate Director, Process Development, to join the Process Development and Analytics group. The successful candidate will be responsible for overseeing early through late stage, upstream, drug substance process development in support of a BLA filing.  The candidate will manage external CDMO partners in the planning and execution of bench scale characterization and validation experiments and associated technical transfer activities.  The successful candidate will have a strong background in Phase I through Phase III/commercial upstream process development, working knowledge of regulatory requirements for an IND and BLA filing, and a demonstrated ability to establish and maintain positive working relationships.

The Associate Director, Process Development will be based in Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Lead early through late-stage cell culture process characterization/validation effort.
  • Experience with preparing for a BLA filing is highly desired.
  • 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 BLA.
  • 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.

Qualifications and Education

  • University degree and a minimum of 10 years’ related experience in upstream process development or equivalent combination of education and experience.
  • Direct experience in process characterization and validation activities including experience with QbD strategies such as FMEA risk assessments, identification of CPPs and CQAs, and justification/establishment of process parameter ranges.
  • Working knowledge of statistical methods and design for process characterization and validation.
  • Previous hands-on experience with cell culture and bench-scale bioreactors.
  • Strong background in the regulatory compliance requirements for the production of biologics for clinical and commercial use.
  • 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.
  • Previous experience working with CDMOs is preferred.

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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