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Zymeworks Inc

Senior Scientist, Process Development – Upstream

Technical & Manufacturing Operations · Seattle, Washington
Department Technical & Manufacturing Operations
Employment Type Permanent - Full Time
Minimum Experience Experienced

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.  

 

Key Responsibilities

• 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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  • Location
    Seattle, Washington
  • Department
    Technical & Manufacturing Operations
  • Employment Type
    Permanent - Full Time
  • Minimum Experience
    Experienced