Downstream Purification Scientist - GMP Scale-Up Leader

Jobless; Bellevue (WA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Vacation & PTO

Medical, Dental & Vision benefits

401K / Pension matching

Employee stock purchase program

Volunteer time off

Job summary

Zymeworks is seeking a senior downstream process development leader for our Bellevue, WA site to advance purification programs in a cGMP environment. You will design scalable purification processes, collaborate across research, analytics, and manufacturing, and guide technology transfer to GMP facilities while ensuring regulatory readiness.

The role requires 8+ years in industry, PhD preferred, and strong data analysis with CQAs, DoE/QbD.

Qualifications

• PhD/MSc/BSc in Chemical/Biochemical Engineering or related with 8+ years industrial downstream development.
• Experience in downstream process development, scale-up, and cGMP manufacturing.
• Experience with contract manufacturing organizations.
• Strong cross-functional collaboration and communication skills.
• Regulatory knowledge of cGMP for biologics.
• Knowledge of QbD/DoE multivariate analysis a plus.

Responsibilities

• Develop robust early phase purification processes for GMP manufacturing.
• Coordinate with research groups on upcoming projects and evaluate manufacturability.
• Collaborate with analytics to establish CQAs and monitor process performance.
• Maintain downstream development databases and analyze data.
• Author and review process development reports, protocols, batch records, and tech transfer docs.
• Provide technical oversight of GMP manufacturing operations.
• Support regulatory filings (IND, IMPD, BLA sections) as required.

Skills

Downstream development

GMP manufacturing

Cross-functional collaboration

Statistical analysis

Regulatory compliance

CMC knowledge

QbD

DoE methods

Education

PhD in Chemical/Biochemical Engineering

MSc in Chemical Engineering

BSc in Chemical Engineering

Job description

Zymeworks is seeking a senior downstream process development leader for our Bellevue, WA site to advance purification programs in a cGMP environment. You will design scalable purification processes, collaborate across research, analytics, and manufacturing, and guide technology transfer to GMP facilities while ensuring regulatory readiness.

The role requires 8+ years in industry, PhD preferred, and strong data analysis with CQAs, DoE/QbD.