Associate Director, Downstream Process Development
Zymeworks Inc.
2 months ago
Remote friendly (Bellevue, WA)
United States
Operations
What You'll Do
- 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 in support of all phases of clinical development, including late clinical phase filings.
- Collaborate with cross-functional teams (Research, Development, Clinical, Quality, Regulatory) to define and execute development strategies for novel biotherapeutics and ADCs.
- Lead project-specific efforts in process development, scale-up, production, and tech transfer within and between CMOs.
- Participate in developing RFPs to solicit project-specific bids from CMOs/CROs.
- Develop SOWs defining work and provide oversight of experiments/activities conducted at CMO/CRO.
- Develop timely, highly productive manufacturing processes for antibody, multispecific, and ADC therapeutics; escalate issues as needed.
- Design, manage, and support process characterization studies; develop control strategies for process validation.
- Author technical documents and deliver presentations to technical and project groups.
- Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
- Work with Analytic Sciences, Manufacturing Sciences and Technology, and Quality teams to plan and implement downstream process development and manufacturing operations.
- Ensure processes meet quality requirements, regulations, policies, and applicable guidelines/procedures.
- Serve as primary point of contact for CMOs; perform person-in-plant duties as needed for technical support.
- Provide technical support for CMC activities including investigations, CAPAs, Change Controls, technology transfers, and lifecycle management of pre-clinical and cGMP manufacturing to meet delivery schedules.
- Author and review technical CMC documentation (protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations).
- Drive timely decisions and facilitate communication between CMOs and Zymeworks.
- Foster cross-functional and external working relationships (CMC, Quality Assurance, Project Management, Clinical Operations, external manufacturing).
- Promote continuous improvement in product quality and productivity.
- Work closely with internal and external resources to ensure DS supply availability.
What You'll Bring
- University degree in science or engineering and a minimum of 8 years of related experience in biopharmaceutical process development and GMP operations (or equivalent combination of education and experience).
- Experience working with contract manufacturing organizations.
- Proven interpersonal skills; able to collaborate cross-functionally and build effective working relationships.
- Excellent organizational skills; able to work in a fast-paced, changing environment.
- Consistent analytical reasoning ability.
- Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE (preferred).
- Strong background in regulatory compliance requirements for cGMP production of biologicals for clinical and commercial use.
- Working knowledge of regulatory guidelines; expertise in CMC, PK, or toxicology across development phases.
- Proficiency with cGMP and ICH guidelines.
Benefits (as stated)
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits (by country)
- Zymelife health and wellness benefits
- Matching RRSP / 401K / Pension program
- Employee Share Purchase Program
- Employee Equity Program
- Paid time off to volunteer in your community
Application/Other
- Role located in Bellevue, WA; minimum of 3 days per week onsite.
- This role is not eligible for relocation or immigration support.
- Pay range: $146,250.00 - $224,250.00 USD per year (US).
- 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 in support of all phases of clinical development, including late clinical phase filings.
- Collaborate with cross-functional teams (Research, Development, Clinical, Quality, Regulatory) to define and execute development strategies for novel biotherapeutics and ADCs.
- Lead project-specific efforts in process development, scale-up, production, and tech transfer within and between CMOs.
- Participate in developing RFPs to solicit project-specific bids from CMOs/CROs.
- Develop SOWs defining work and provide oversight of experiments/activities conducted at CMO/CRO.
- Develop timely, highly productive manufacturing processes for antibody, multispecific, and ADC therapeutics; escalate issues as needed.
- Design, manage, and support process characterization studies; develop control strategies for process validation.
- Author technical documents and deliver presentations to technical and project groups.
- Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
- Work with Analytic Sciences, Manufacturing Sciences and Technology, and Quality teams to plan and implement downstream process development and manufacturing operations.
- Ensure processes meet quality requirements, regulations, policies, and applicable guidelines/procedures.
- Serve as primary point of contact for CMOs; perform person-in-plant duties as needed for technical support.
- Provide technical support for CMC activities including investigations, CAPAs, Change Controls, technology transfers, and lifecycle management of pre-clinical and cGMP manufacturing to meet delivery schedules.
- Author and review technical CMC documentation (protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations).
- Drive timely decisions and facilitate communication between CMOs and Zymeworks.
- Foster cross-functional and external working relationships (CMC, Quality Assurance, Project Management, Clinical Operations, external manufacturing).
- Promote continuous improvement in product quality and productivity.
- Work closely with internal and external resources to ensure DS supply availability.
What You'll Bring
- University degree in science or engineering and a minimum of 8 years of related experience in biopharmaceutical process development and GMP operations (or equivalent combination of education and experience).
- Experience working with contract manufacturing organizations.
- Proven interpersonal skills; able to collaborate cross-functionally and build effective working relationships.
- Excellent organizational skills; able to work in a fast-paced, changing environment.
- Consistent analytical reasoning ability.
- Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE (preferred).
- Strong background in regulatory compliance requirements for cGMP production of biologicals for clinical and commercial use.
- Working knowledge of regulatory guidelines; expertise in CMC, PK, or toxicology across development phases.
- Proficiency with cGMP and ICH guidelines.
Benefits (as stated)
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits (by country)
- Zymelife health and wellness benefits
- Matching RRSP / 401K / Pension program
- Employee Share Purchase Program
- Employee Equity Program
- Paid time off to volunteer in your community
Application/Other
- Role located in Bellevue, WA; minimum of 3 days per week onsite.
- This role is not eligible for relocation or immigration support.
- Pay range: $146,250.00 - $224,250.00 USD per year (US).