Strategic Associate Director, Downstream Processing

Zymeworks Inc.; Bellevue (WA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary package

Medical, dental, vision benefits

Hybrid work arrangement

Job summary

Zymeworks Inc. in Bellevue, WA seeks an Associate Director of Downstream Process Development to lead the strategy and execution of our downstream operations.

This hybrid role requires onsite presence at least three days per week and a track record of managing complex biopharmaceutical processes. The successful candidate will drive development, scale-up, tech transfer, and CMC documentation across cross-functional teams, collaborating with Research, Development, Quality, and Regulatory to meet

Qualifications

• University degree in science or engineering with 8+ years in biopharmaceutical process development and GMP operations.
• Experience working with contract manufacturing organizations (CMOs).
• Strong collaboration skills and ability to lead cross-functional teams.

Responsibilities

• Serve as a strategic manager for downstream process development and production operations to drive timelines.
• Direct planning of downstream development and manufacturing for all clinical phases including late filings.
• Lead cross-functional collaboration to define and execute development strategies for biotherapeutics and ADCs.
• Manage process development, scale-up, production, and tech transfer across CMOs/CROs.
• Develop SOWs and oversee experiments at CMOs/CROs.
• Design and implement robust manufacturing processes for antibodies, multispecifics, and ADCs.
• Support regulatory submissions and cGMP documentation.

Skills

Downstream process development

Cross-functional collaboration

GMP operations

Project leadership

Education

University degree in science or engineering

Experience with cGMP biologicals

Tools

DoE methods

QbD

Regulatory guidelines

Job description

Zymeworks Inc. in Bellevue, WA seeks an Associate Director of Downstream Process Development to lead the strategy and execution of our downstream operations.

This hybrid role requires onsite presence at least three days per week and a track record of managing complex biopharmaceutical processes. The successful candidate will drive development, scale-up, tech transfer, and CMC documentation across cross-functional teams, collaborating with Research, Development, Quality, and Regulatory to meet