Associate Director, Downstream Process Development

Company Description

Zymeworks is a publicly listed (NASDAQ:

ZYME) clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks' suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop antibody-based therapeutic candidates. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, and Singapore.

Why Work With Us

Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite.

What You'll Do

* Serves as a strategic manager for the company's downstream process development and production operations to drive program timelines.

* Directs the strategic planning of downstream process development and manufacturing in support of all phases of clinical development including support of late clinical phase filings.

* Collaborates within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for novel biotherapeutics and ADCs.

* Leads project-specific efforts in process development, scale-up, production and tech transfer of processes within and between CMOs.

* Participates in the development of RFP's to solicit project specific bids from CMOs/CROs.

* Develops SOWs defining work to be performed and provide subsequent oversight of experiments and activities conducted at the CMO/CRO.

* Develops highly productive manufacturing processes in a timely manner for novel antibody, multispecific and ADC therapeutics. Brings issues to the attention of appropriate personnel as necessary.

* Designs, manages and supports process characterization studies and develops control strategies for process validation.

* Authors technical documents and deliver presentations to technical and project groups.

* Contributes to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).

* Works directly with Analytic Sciences, Manufacturing Sciences and Technology and Quality teams to plan and implement execution of downstream process development and manufacturing operations.

* Ensures that all developed processes are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.

* Serves as primary point of contact with contract manufacturing organizations (CMOs) and performs person-in-plant duties as needed to provide technical support for ongoing manufacturing.

* Provides technical support for all CMC activities, including investigations, CAPAs, Change Controls, technology transfers, operation and lifecycle management of pre-clinical and cGMP manufacturing processes, ensuring all product delivery schedules are met.

* Authors and reviews technical CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls and deviations.

* Drives timely decisions and facilitates active communication and information flow between CMOs and Zymeworks team members.

* Fosters strong, long-lasting cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and external manufacturing entities to ensure successful development and manufacture of all products.

* Promotes a culture of continuous improvement in product quality and productivity.

* Works closely with all 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 related experience in biopharmaceutical process development and GMP operations or an equivalent combination of education and experience.

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