Zymeworks

Vice President, Biologics Technical Operations

Manufacturing - Seattle, Washington

Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated product candidates.

Zymeworks is seeking a Vice President, Biologics Technical Operations to provide leadership and strategic oversight of clinical and commercial technical activities in support of Zymeworks’ biologics product portfolio.

This position will be based in Seattle and will report to the Senior Vice President, Technical & Manufacturing Operations.

Key Responsibilities

• Work collaboratively with the Technical Operations Leadership Team to create and execute against strategic development plans
• Provide leadership and direction to the Biologics Technical organization, including Process & Analytical Development and Manufacturing Science & Technology
• Provide strategic direction and execute on strategies to advance biologics candidates in pipeline by providing overall CMC technical oversight
• Lead and develop a high-performing technical team responsible for the biologics projects from early phase through commercialization
• Executes on development timelines and strategies for new biologics candidates to enable successful IND and BLA submissions
• Develop and execute drug substance and drug product PPQ studies in alignment with Manufacturing and Technical Operations through our third party CDMO network
• Evaluate and implement new technologies to drive innovation in biologics development, testing, and manufacturing
• Drive development and implementation of new systems to improve project execution and data management
• Lead technical activities in collaboration with Program Management, Project Management, Quality Assurance, Quality Control, and Supply Chain
• Ensure strong relationships with Discovery Research, Clinical Operations, IT, Finance, Business Operations, People Team and our External Supplier Network
• Support regulatory filings by guiding the draft, review, and approval of CMC sections and supporting associated agency interactions and audits/regulatory inspections
• Provide technical support to internal and external cGMP manufacturing operations
• Develop and manage departmental budget
• Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care

Qualifications and Experience

• PhD in a Biological Science, Biochemist Chemical Engineering or related discipline
• Minimum 15 years of biopharmaceutical industry experience with at least 10 years’ experience managing teams and focusing on biologics manufacturing process development utilizing mammalian cell lines. (may consider and equivalent combination of education and experience)
• Experience leading cross-functional biologics development (CMC) teams consisting of representatives from multiple functions such as Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation/Drug Product Process Development, and Analytical Operations
• Experience supporting multiple regulatory filings including INDs/BLAs and supporting product-related inspections for US and foreign regulatory agencies
• Experience developing, implementing and executing strategic plans and objectives for organizations and departments
• Experience working with external manufacturing and testing organizations
• Experience with antibody drug conjugates (ADCs)
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
• Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation
• Exceptional interaction, leadership and command skills are required
• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision
• Domestic and international travel (~10%) as needed

Why Work for Us?

At Zymeworks, we stand for innovation, integrity, collaboration and care.

We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

How to Apply

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.

Zymeworks

Zymeworks is an Equal Opportunity Employer

Submitted: 03/13/2021