Associate Director, Downstream Process Development
About The Position
The Associate Director, Downstream Process Development serves as a strategic manager for downstream process development and production operations, driving program timelines. The role directs planning for downstream process development and manufacturing across clinical development phases, including support for late-stage clinical filings. It collaborates with Research, Development, Clinical, Quality, and Regulatory teams to define and execute strategies for novel biotherapeutics and antibody-drug conjugates (ADCs). The position leads process development, scale-up, production, and technology transfer activities within and between contract manufacturing organizations (CMOs). It oversees CMO/CRO work through requests for proposals, statements of work, and technical oversight, and serves as a primary CMO contact, providing on-site technical support as needed. The role also supports process characterization, control-strategy development, manufacturing operations, and lifecycle management for preclinical and cGMP processes. The Associate Director authors and reviews CMC and technical documentation, contributes to regulatory submissions and updates (including IND and BLA filings), and provides technical support for investigations, CAPAs, change controls, technology transfers, and manufacturing activities. The role ensures processes meet applicable quality and regulatory requirements, supports product supply schedules, promotes continuous improvement in quality and productivity, and maintains effective collaboration among internal teams and external manufacturing partners.
Requirements
- University degree in science or engineering, and at least 8 years of related experience in biopharmaceutical process development and GMP operations, or an equivalent combination of education and experience.
- Experience working with contract manufacturing organizations.
- Strong interpersonal skills and ability to collaborate as part of a cross-functional team and maintain effective working relationships.
- Excellent organizational skills and ability to work effectively in a fast-paced, changing environment.
- Consistent analytical reasoning ability.
- Strong background in regulatory compliance requirements for cGMP production of biological products for clinical and commercial use.
- Working knowledge of regulatory guidelines and expertise in CMC, PK, or toxicology for advancing therapeutics through different development phases.
- Proficiency with cGMP and ICH guidelines.
Nice To Haves
- Familiarity with Quality by Design (QbD) and control strategy development, or multivariate analysis and Design of Experiments (DoE) approaches to process development.
Responsibilities
- Direct strategic planning of downstream process development and manufacturing in support of clinical development phases, including late clinical phase filings.
- Collaborate with cross-functional Research, Development, Clinical, Quality, and Regulatory teams to define and execute development strategies for novel biotherapeutics and ADCs.
- Lead process development, scale-up, production, and technology transfer within and between CMOs.
- Participate in developing RFPs to solicit project-specific bids from CMOs and CROs.
- Develop statements of work and oversee experiments and activities conducted at CMOs and CROs.
- Develop productive manufacturing processes for novel antibody, multispecific, and ADC therapeutics, escalating issues as appropriate.
- Design, manage, and support process characterization studies and develop control strategies for process validation.
- Author technical documents and deliver presentations to technical and project groups.
- Contribute to CMC portions of regulatory submissions and updates, including IND and BLA filings.
- Plan and implement downstream process development and manufacturing operations with Research and Development, Analytic Sciences, Technology, and Quality teams.
- Ensure developed processes comply with quality requirements, regulations, policies, applicable guidelines, and procedures.
- Serve as the primary point of contact with CMOs and provide person-in-plant technical support for ongoing manufacturing as needed.
- Provide technical support for CMC activities, including investigations, CAPAs, change controls, technology transfers, and operation and lifecycle management of preclinical and cGMP manufacturing processes.
- Author and review CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls, and deviations.
- Facilitate timely decisions and communication between CMOs and Zymeworks team members.
- Build cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and manufacturing partners.
- Promote continuous improvement in product quality and productivity.
- Coordinate internal and external resources to ensure drug substance supply availability.
Benefits
- Industry-leading vacation and paid time off.
- Medical, dental, and vision benefits by country.
- Zymelife health and wellness benefits.
- Matching RRSP, 401(k), or pension program.
- Employee Share Purchase Program.
- Employee Equity Program.
- Paid time off to volunteer in the community.
- Competitive salaries and opportunities for professional growth.
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What This Job Offers
Job Type
Full-time
Career Level
Director
