Senior Scientist, Purification Process Development

Senior Scientist, Purification Process Development Company Description

Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig.

In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore.

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.

• Responsible for developing a robust early phase process specifically related to all purification operations.
• Develop scalable purification processes suitable for GMP manufacturing.
• Coordinate with research group on upcoming projects and evaluate manufacturability.
• Collaborate with analytical development to establish critical quality attributes (CQAs) and monitor process performance.
• Maintain downstream database for purification development data, reports, purification related raw materials, equipment, and process history, and analyze downstream data using statistical analysis or other methods.
• Author and review process development reports, technical protocols, batch records, SOPs, risk assessments, and technology transfer documentation.
• Serve as subject matter expert to plan, review, approve, monitor, and analyze process development experiments, GMP manufacturing and investigations.
• Responsible for late-stage purification process characterization; performing risk analysis, defining control strategy and process qualification.
• Collaboration with external CDMO partners to ensure successful scale-up and technology transfer to GMP facility.
• Review executed batch documentation in support of batch release.
• Author relevant sections of regulatory filings, including IND, IMPD and sections of BLA, and provide responses to health authorities as required.
• Provide technical oversight and support of GMP manufacturing operations.
• Effectively communicate with managers, peers, and external partners, to comprehend downstream progress, present process data and trending results, and update manufacturing performance.
• Establish and maintain positive working relationships with peers, management and external partners.
• Works closely with all internal and external resources to ensure DS supply availability.

• A PhD, MSc, or BSc, in Chemical/Biochemical Engineering, Biological Sciences or related disciplines with at least 8 years (5+ years for PhD) of industrial experience in downstream process development with some GMP manufacturing experience.
• Experienced in downstream process development, characterization, scale-up and manufacturing in the cGMP environment.
• Experience working with contract manufacturing organizations.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
• Excellent oral and written communication skills, including the ability to integrate complex data to produce clear and accurate reports and presentations.
• Strong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use.
• Working knowledge of regulatory…