Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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.
About the Position
The Senior Scientist, Process Development will be responsible for overseeing early through late stage, upstream, drug substance process development in support of a BLA filing. The position will manage external CDMO partners in the planning and execution of bench scale characterization and validation experiments and associated technical transfer activities.
• Lead early through late-stage cell culture process characterization/validation effort.
• Manage 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 and review 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 guidance for manufacturing operations and technology transfer.
• Manages critical-path components of scientific activities, issue escalation, problem solving and contingency planning.
• Ensures adherence to best practices and explores opportunities for continuous improvement and provides input into best practices.
• Actively works to foster an environment of effective and collaborative working relationships amongst employees, management and external partners.
Qualifications 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
• 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.
• Strong background in Phase I through Phase III/commercial upstream process development.
• Significant knowledge of regulatory requirements for a IND and BLA filing.
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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