Director/Senior Director, Manufacturing Operations

Manufacturing Seattle, Washington


Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. 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.

Company 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.

About the Position

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

Key Responsibilities:

  • Participates in strategic and long-term direction of the manufacturing business unit. Works with Senior Management to develop and implement programs, strategies, and processes. Ensures department and operational activities are aligned with corporate objectives.
  • Directs the execution of the manufacturing strategy to ensure that enough drug substance and drug product are available to meet all clinical and/or commercial supply chain requirements.
  • Participates In the management of the CMC sections of IND and BLA regulatory submissions.
  • Plans program activities and oversees the external contract development & manufacturing organizations (CDMOs) with input from functional leads and colleague’s instrumental in supply forecasting and planning.
  • Works with project team leads and project managers to develop timelines and resource plans.
  • Hire and manages employees by monitoring performance, encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge.
  • Provides regular project updates to the business unit leads in the Technical & Manufacturing Operations department.
  • Manages and operates in a state or regulatory compliance to ensure the highest quality of product is delivered to our patients.
  • Leads through example to establish an environment fostering effective and collaborative working relationships.
  • Works directly with the Quality unit to resolve quality system related items, including change controls, deviations, CAPAs, audits, etc.
  • Institutes and continuously improves operating procedures and policies ensuring “best in class”.
  • Manages the preparation of operating and personnel budgets and plans. Ensures budgets, schedules and performance requirements are met.
  • Participates in activities relating to sourcing and selecting CDMOs.
  • Provides analytical and strategic feedback regarding 3rd party alliance opportunities
  • Prepares and reviews project-related documents, patent and regulatory submissions, drug dossiers and research reports.

Education and Experience: 

A minimum of a Bachelor of Science degree (or equivalent) and a minimum of 15 years’ related experience or an equivalent combination of education and experience.  Previous supervisory experience required.

Skills and Abilities:

  • Proven interpersonal skills with the ability to work collaboratively as a member of a Technical and Manufacturing Operations (TMO) Sr. Leadership team. Ability to establish and maintain effective cross-functional working relationships.
  • Biologics manufacturing experience required
  • Strong leadership skills with the proven ability to manage, develop and empower employees.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Strong ability to work with strategic partners and external CDMO organization to achieve project success.
  • Able to think and act strategically, anticipate roadblocks and map out next steps.
  • Demonstrated high level of integrity and ethics.
  • Consistent analytical reasoning ability.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners who 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. 

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