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Zymeworks
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, Process Development – Upstream to join the Process Development and Analytics group. The candidate will be responsible for providing technical insight to internal and external partners in upstream process development and manufacturing activities. The successful candidate will have a strong background in mammalian cell culture process development, demonstrated experience in technical writing, and proven ability to establish and maintain positive working relationships.
The Scientist, Upstream Process Development will be based in Seattle, WA.
Key Responsibilities:
- Collaborate with external partners to plan, review, approve, monitor, analyze, and summarize bench scale mammalian cell culture process development experiments which may range from cell line development through phase III/commercial process development.
- Review and approve technical documents including scopes of work, protocols, summary reports, technical transfer documents, master batch records, and executed master batch records.
- Organize, maintain and analyze internal archive of data and reports generated by CDMO partners.
- Author relevant sections of regulatory filings.
- Collaborate with internal partners in the process and analytical development group, manufacturing and technical operations, project management, regulatory and quality assurance to achieve project objectives.
- Provide technical support for manufacturing operations and technology transfer.
- Establish and maintain positive working relationships with peers, management and external partners.
Skills and Abilities:
- University degree and a minimum of 5 years’ related experience in upstream mammalian cell culture process development or equivalent combination of education and experience.
- Direct experience in clinical stage process development activities in an industrial setting.
- Working knowledge of statistical methods for design of experiments using JMP software.
- Established, hands-on experience with mammalian, suspension, cell culture technique and bench-scale bioreactor operations.
- Solid technical writing skills, including knowledge of expected content and format.
- 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 working with CDMOs, writing regulatory documents, and experience in cell line development and/or harvest operations is desirable but not required.
Why Work for Us?
At Zymeworks, we stand for innovation, integrity, collaboration and 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: 03/06/2021
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