Senior Purification Process Scientist (Hybrid)

Zymeworks Inc.; Bellevue (WA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Vacation & PTO

Medical, dental & vision benefits

Employee Share Purchase Program

Employee Equity Program

Volunteer time off

Job summary

Zymeworks Inc. in Bellevue, WA seeks a Senior Scientist for Purification Process Development, delivering robust early-phase purification strategies aligned with GMP manufacturing. The role partners with R&D, analytical development, and external CDMOs, shaping CQAs and transfer docs.

The ideal candidate holds a PhD/MSc/BSc with 8+ years in downstream development within a cGMP context and excels at cross-functional teamwork, data analysis, and regulatory support for IND/IMPD/BLA filings.

Qualifications

• PhD/MSc/BSc with 8+ years in industrial downstream process development and GMP familiarity.
• Experience in downstream process development, scale-up, and cGMP manufacturing.
• Experience working with contract manufacturing organizations (CDMOs).
• Strong cross-functional collaboration and communication skills.
• Ability to analyze complex data and generate clear reports/presentations.

Responsibilities

• Develop robust early-phase purification processes for GMP manufacturing.
• Scale-up purification processes and ensure manufacturability.
• Coordinate with research groups on new projects and assess transfer feasibility.
• Collaborate with analytical development to define CQAs and monitor process performance.
• Maintain purification development data, materials, equipment, and process history and analyze data.
• Author/review process development reports, protocols, batch records, SOPs, risk assessments and tech transfer docs.
• Provide oversight for GMP manufacturing experiments and investigations; support regulatory filings (IND/IMPD/BLA).
• Collaborate with external CDMOs to ensure successful scale-up and tech transfer to GMP facilities.
• Review batch documentation for release and ensure DS supply availability.

Skills

Downstream process development

GMP manufacturing

Cross-functional collaboration

Regulatory understanding (CMC/IND)

Data interpretation & reporting

Process transfer & tech transfer

Education

PhD in Chemical/Biochemical Engineering or related

MSc in Chemical/Biochemical Engineering or related

BSc in Chemical/Biological sciences

Tools

Job description

Zymeworks Inc. in Bellevue, WA seeks a Senior Scientist for Purification Process Development, delivering robust early-phase purification strategies aligned with GMP manufacturing. The role partners with R&D, analytical development, and external CDMOs, shaping CQAs and transfer docs.

The ideal candidate holds a PhD/MSc/BSc with 8+ years in downstream development within a cGMP context and excels at cross-functional teamwork, data analysis, and regulatory support for IND/IMPD/BLA filings.