Associate Director, Analytical Development

Process Development 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, 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.

Zymeworks is currently seeking an Associate Director, Analytical Development to join the Process Development and Analytics group. The successful candidate will be accountable for all phases of analytical method development and product characterization as well as supporting the GMP manufacture of novel therapeutic antibodies and antibody drug conjugates. This position is responsible for leading the analytical activities and supporting manufacturing collaboration with contract manufacturing organizations and quality control groups. This will include visits to development and manufacturing sites as necessitated by the ongoing activities. Cross-functional collaboration with other departments, including project management, clinical, quality assurance and regulatory will be routinely required.

The Associate Director, Analytical Development will be based in Seattle, WA and will report to the head of the Process Development and Analytics department.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Contributes their expertise to the strategic planning, direction and support of analytical method development and biochemical characterization for all phases of process development from first in human to late clinical phase and commercial filings.
  • Collaborates within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for biotherapeutics including ADCs.
  • Supports the method development, qualification and validation of methods for biotherapeutics.
  • 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.
  • 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).
  • Designs, manages and supports product characterization studies.
  • Ensures that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.

Qualifications and Education

  • University degree in analytical science, biochemistry or biophysics and a minimum of 10 years’ related experience in the pharmaceutical or biotechnology field.
  • Experience with protein mass spectrometry, chromatography, capillary electrophoresis, cell-based bioassay and other analytical techniques is desired.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Consistent analytical reasoning ability.
  • Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings.
  • Strong background in the regulatory compliance requirements for the production of biologicals and ADCs for clinical and commercial use.

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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