Senior Purification Process Scientist, GMP Scale-Up

Zymeworks-Inc; Bellevue (WA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Vacation & paid time off

Excellent medical, dental & vision

Employee Share Purchase Program

Employee Equity Program

Volunteer time off

Job summary

Zymeworks in Bellevue, WA seeks a Senior Scientist, Purification Process Development to lead early-phase purification strategies and deliver scalable GMP-ready processes.

You will collaborate with research, analytical development and external CDMOs to enable tech transfer, establish CQAs and monitor process performance.

This role requires strong scientific communication, regulatory familiarity for IND/IMPD/BLA sections, and a track record in cGMP downstream development.

Qualifications

• PhD, MSc or BSc in Chemical/Biochemical Engineering or Biological Sciences with 8+ years of industrial experience.
• Experience in downstream purification development, scale-up and GMP manufacturing.
• Experience with contract manufacturing organizations (CMOs).
• Strong data interpretation and ability to present complex results clearly.

Responsibilities

• Lead early-phase purification process development and scalable GMP processes.
• Coordinate with R&D, analytical development and external CDMOs for tech transfer.
• Establish CQAs, monitor process performance, and manage data/records.
• Author and review regulatory sections and submission documents as required.
• Provide technical oversight of GMP manufacturing operations and risk analysis.

Skills

Downstream process development

GMP manufacturing

Cross-functional collaboration

CQAs & process monitoring

Regulatory filings knowledge

Statistical analysis

Documentation & reporting

DoE / multivariate analysis

Tech transfer to CDMO

Education

PhD / MSc / BSc in Chemical/Biochemical Engineering or Biological Sciences

Tools

LIMS

DoE software

Job description

Zymeworks in Bellevue, WA seeks a Senior Scientist, Purification Process Development to lead early-phase purification strategies and deliver scalable GMP-ready processes.

You will collaborate with research, analytical development and external CDMOs to enable tech transfer, establish CQAs and monitor process performance.

This role requires strong scientific communication, regulatory familiarity for IND/IMPD/BLA sections, and a track record in cGMP downstream development.