Senior Scientist, Purification Process Development

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.

About the role

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

Responsibilities

• Develop 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.
• Collaborate 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.
• Work closely with all internal and external resources to ensure DS supply availability.

Requirements

• 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 guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development.
• Proficiency with cGMP and ICH guidelines.
• Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.
• Experience working in a GMP manufacturing environment a plus.

Benefits

• Industry leading vacation and paid time off
• Exceptional medical, dental and vision benefits by country
• Zymelife health and wellness benefits
• Matching RRSP / 401K / Pension program
• Employee Share Purchase Program
• Employee Equity Program
• Paid time off to volunteer in your community

Pay

The base salary range for this role is $116,250 - $178,250 USD per year. Within the range, individual pay is determined by a variety of factors including job-related knowledge, education, training, skills, and experience.

Schedule

Hybrid with a minimum of 3 days per week onsite.