Associate Director, Downstream Process Development

Zymeworks Inc.•Bellevue, WA

About The Position

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.

Requirements

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.
Experience working with contract manufacturing organizations.
Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
Consistent analytical reasoning ability.
Strong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use.
Working knowledge of regulatory guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development.
Proficiency with cGMP and ICH guidelines.

Nice To Haves

Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.

Responsibilities

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.