Zymeworks

Senior Scientist, Process Development - Upstream

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 technical oversight of drug substance, upstream process development projects. The candidate will manage external CDMO partners in the planning and review of bench-scale experiments to support either Phase I/II clinical trials or commercialization. The successful candidate will have broad experience with various stages of upstream process development, including cell line and harvest development activities.

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

Key Responsibilities:

• Provide technical oversight for either early or late phase cell culture process development/characterization
• Collaborate with external partners to plan, review, approve, monitor, and analyze bench-scale process development experiments.
• Review and approve technical documents including scopes of work, protocols, development plans, summary reports, technical transfer documents, and masterbatch records.
• Organize and maintain the internal archive of raw data and reports generated by CDMO partners.
• Author relevant sections of regulatory filings.
• Provide technical support to internal partners including manufacturing operations, project management, regulatory, business development and quality groups.
• 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 in upstream process development or equivalent combination of education and experience.

Skills and Abilities:

• Previous hands-on experience with mammalian cell culture and bench-scale bioreactors.
• Working knowledge of statistical methods and design of experiments.
• Demonstrated technical writing skill.
• Experience writing CMC sections of regulatory filings.
• 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.
• Previous experience managing CDMOs is preferred.
• Familiarity with cell line development or harvest development is preferred.

Why Work for Us?

Innovation. Act with Integrity. Collaboration. 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.

How to Apply

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.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 12/18/2020