Director, Manufacturing Science & Technology

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, initially focused on the treatment of cancer.  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

Zymeworks is searching for a Director, Manufacturing Science & Technology (MS&T) to join our Seattle, WA team.  The Director of MS&T is responsible for scientific and technical oversight for Zymeworks’ biologics manufacturing processes from Phase 3 process characterization through commercialization and life cycle management.  The candidate will lead a team of MS&T scientists and engineers to support external network of biologics drug substance and drug product manufacturing, including occasional site visits, raw material tracking, process data management, manufacturing performance trending and improvement. 

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

Key Responsibilities

  • Direct oversight of late stage development activities for biologic therapeutics using mammalian cell culture system. The responsibilities include process characterization, process performance qualification, BLA fling, pre-approval inspection, commercial manufacturing monitoring and improvement, and life cycle management.
  • Lead a team of engineers and scientists, with expertise in upstream/downstream/drug product manufacturing, analytics, and process data analysis.
  • Provide strong leadership for establishing best in class process validation, process robustness, and continuous improvements in commercial manufacturing.
  • Deliver on company objectives related to new product introduction, supply continuity, and manufacturing productivity.
  • Drive effective partnerships with peers in Process and Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers
  • Effectively communicate with senior leaders, peers, staff, and external partners, to outline the MS&T strategy, coordinate internal/external efforts, and update manufacturing and drug supply status.
  • Oversee the technical support for process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.
  • Prepare documents supporting development and manufacturing activities, and for regulatory filings and inspections.
  • Lead cross-functional strategic teams and collaborate with internal and external partners/CDMOs to build productive relationships, to ensure the continuous supply of top-quality therapeutics for patients.

Qualifications and Experience

  • A PhD (preferred), MS, or BS, in Chemical/Biochemical Engineering or Biological Sciences or related disciplines with at least 10 years of industrial experiences in relevant fields. A strong track record of leading and managing technical support activities for biologics bulk drug manufacturing.  Broad knowledge of bulk biologics analysis, upstream and/or downstream processing, drug substance and drug product formulation, process characterization, scale-up and manufacturing in cGMP environment, with proven expertise and experiences in several of these fields. The candidate also needs to have a proven ability to lead multi-functional teams and experience in managing manufacturing projects with external CDMOs.

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. 

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.

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