Senior Leader, Downstream Process Development (Hybrid)

Zymeworks-Inc; Bellevue (WA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Industry leading vacation

Medical, dental and vision benefits

Employee Share Purchase Program

Paid time off to volunteer

Job summary

Zymeworks in Bellevue, WA, seeks an Associate Director for Downstream Process Development. Hybrid work with at least three days on-site. Lead downstream development, scale-up, and tech transfer across CMOs/CROs to support clinical programs.

The role requires a science/engineering degree and 8+ years in biopharmaceutical process development with strong regulatory and cross-functional skills. You will drive process characterization, CMC documentation, and collaboration with Quality, Regulatory,

Qualifications

• University degree in science or engineering required.
• Minimum 8 years of biopharmaceutical process development and GMP operations experience.
• Experience with contract manufacturing organizations (CMOs/CROs).
• Strong cross-functional collaboration and communication skills.
• Knowledge of cGMP and regulatory guidelines for biologics.

Responsibilities

• Serve as a strategic manager for downstream process development and production operations to drive program timelines.
• Direct strategic planning of downstream process development and manufacturing across clinical development phases.
• Collaborate with Research, Development, Clinical, Quality, Regulatory to define development strategies.
• Lead project-specific efforts in process development, scale-up, production and tech transfer between CMOs.
• Develop SOWs and oversee experiments at CMOs/CROs.
• Develop manufacturing processes for antibodies, multispecifics, and ADCs; escalate issues as needed.
• Design and support process characterization studies and control strategies for validation.
• Prepare technical CMC documentation and present to project teams.
• Work with R&D, Analytic Sciences, Technology and Quality to implement downstream operations.
• Ensure processes comply with quality requirements and regulatory guidelines.
• Serve as primary contact with CMOs and provide on-site technical support as needed.
• Provide technical support for all CMC activities, including investigations and change controls.
• Author and review CMC documents including protocols and batch records.

Skills

Cross-functional collaboration

Regulatory knowledge

Project management

Analytical reasoning

DoE methods

QbD

Education

University degree in science or engineering

Job description

Zymeworks in Bellevue, WA, seeks an Associate Director for Downstream Process Development. Hybrid work with at least three days on-site. Lead downstream development, scale-up, and tech transfer across CMOs/CROs to support clinical programs.

The role requires a science/engineering degree and 8+ years in biopharmaceutical process development with strong regulatory and cross-functional skills. You will drive process characterization, CMC documentation, and collaboration with Quality, Regulatory,