Senior Scientist, Purification Process Development
Zymeworks Inc.
August 19, 2026
Remote friendly (Bellevue, WA)
United States
Operations
What You'll Do:
- Develop early-phase purification processes for all purification operations.
- Develop scalable purification processes suitable for GMP manufacturing.
- Coordinate with research on upcoming projects and evaluate manufacturability.
- Collaborate with analytical development to establish CQAs and monitor process performance.
- Maintain downstream database for purification data, analyze data (e.g., statistical analysis).
- Author/review process development reports, technical protocols, batch records, SOPs, risk assessments, and technology transfer documentation.
- Act as subject matter expert for planning/review/approving/monitoring/analyzing process development experiments, GMP manufacturing, and investigations.
- Perform late-stage purification characterization, risk analysis, define control strategy, and support process qualification.
- Collaborate with external CDMO partners for scale-up and technology transfer to GMP.
- Review executed batch documentation to support batch release.
- Author regulatory filing sections (IND, IMPD, BLA) and respond to health authorities as required.
- Provide technical oversight and support for GMP manufacturing operations.
- Communicate downstream progress, data/trending, and updates to manufacturing performance.
What You'll Bring:
- PhD/MSc/BSc in Chemical/Biochemical Engineering or Biological Sciences (or related) with 8+ years industrial experience (5+ years for PhD) in downstream process development with some GMP experience.
- Downstream process development/characterization/scale-up and cGMP manufacturing experience.
- Experience with CDMOs.
- Strong collaboration, organization, communication, and regulatory compliance knowledge for cGMP biologicals.
- Working knowledge of regulatory guidelines; expertise in CMC/PK/toxicology.
- Proficiency with cGMP and ICH.
- Familiarity with QbD/Control Strategy or multivariate analysis and DoE (plus).
- Experience in GMP manufacturing environment (plus).
Total Rewards Package (includes):
- Vacation/PTO; medical/dental/vision; Zymelife wellness; matching RRSP/401K/pension; employee share purchase; employee equity; paid volunteer time.
Application instructions:
- Not eligible for relocation or immigration support.
- Develop early-phase purification processes for all purification operations.
- Develop scalable purification processes suitable for GMP manufacturing.
- Coordinate with research on upcoming projects and evaluate manufacturability.
- Collaborate with analytical development to establish CQAs and monitor process performance.
- Maintain downstream database for purification data, analyze data (e.g., statistical analysis).
- Author/review process development reports, technical protocols, batch records, SOPs, risk assessments, and technology transfer documentation.
- Act as subject matter expert for planning/review/approving/monitoring/analyzing process development experiments, GMP manufacturing, and investigations.
- Perform late-stage purification characterization, risk analysis, define control strategy, and support process qualification.
- Collaborate with external CDMO partners for scale-up and technology transfer to GMP.
- Review executed batch documentation to support batch release.
- Author regulatory filing sections (IND, IMPD, BLA) and respond to health authorities as required.
- Provide technical oversight and support for GMP manufacturing operations.
- Communicate downstream progress, data/trending, and updates to manufacturing performance.
What You'll Bring:
- PhD/MSc/BSc in Chemical/Biochemical Engineering or Biological Sciences (or related) with 8+ years industrial experience (5+ years for PhD) in downstream process development with some GMP experience.
- Downstream process development/characterization/scale-up and cGMP manufacturing experience.
- Experience with CDMOs.
- Strong collaboration, organization, communication, and regulatory compliance knowledge for cGMP biologicals.
- Working knowledge of regulatory guidelines; expertise in CMC/PK/toxicology.
- Proficiency with cGMP and ICH.
- Familiarity with QbD/Control Strategy or multivariate analysis and DoE (plus).
- Experience in GMP manufacturing environment (plus).
Total Rewards Package (includes):
- Vacation/PTO; medical/dental/vision; Zymelife wellness; matching RRSP/401K/pension; employee share purchase; employee equity; paid volunteer time.
Application instructions:
- Not eligible for relocation or immigration support.