Scientist/Senior Scientist, Analytical Development

Process Development 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 currently seeking a Scientist/Senior Scientist, Analytical Development to join the Process Development and Analytics group. The successful candidate will oversee all phases of analytical method development and product characterization as well as support the GMP manufacture of novel therapeutic antibodies and antibody drug conjugates currently performed at contract manufacturing and research organizations. Cross-functional collaboration with other departments, including project management, clinical, quality, and regulatory will be routinely required.

The Scientist/Senior Scientist, Analytical Development will be based in Seattle, WA and will report to the Associate Director, Analytical Development.

Key Responsibilities:

  • Contributes 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.
  • Collaborates within cross-functional teams (Research, Development, Clinical, Quality, Regulatory) to define and execute development strategies for biotherapeutics, including ADCs.
  • Supports the development, qualification, and validation of methods for biotherapeutics at CDMOs/CROs.
  • Ensures that all developed methods are compatible with quality requirements, including regulations, policies, applicable guidelines, and procedures.
  • Performs data organization and analysis; experienced with statistical approaches and software.
  • Participates in the development of RFP’s to solicit project-specific bids from CDMOs/CROs.
  • Develops SOWs defining work to be performed and provides subsequent oversight of experiments and activities conducted at the CDMO/CRO.
  • Authors technical documents and delivers presentations to technical and project groups.
  • Contributes to the preparation of CMC portions of regulatory submissions and updates.
  • Manages critical-path components of scientific activities, issue escalation, problem solving, and contingency planning.
  • Ensures adherence to best practices and explores opportunities for continuous improvement and provides input into best practices.
  • Actively works to promote effective and collaborative working relationships amongst employees, management, and external partners.

Qualifications and Experience: 

University degree in an analytical science, cell biology, immunology, biochemistry, biophysics or similar and a minimum of 5 years’ related experience in the pharmaceutical or biotechnology fields.

Skills and Abilities:

  • Experience within analytical development and/or quality control groups executing analytical testing of protein biologics.
  • Experience with ELISAs and/or cell-based assays for potency testing of protein biotherapeutics, including method development, troubleshooting, and/or GMP method qualification/validation.
  • Experience with other analytical techniques used for protein biologics, such as chromatography, capillary electrophoresis, spectrophotometry, protein mass spectrometry, or compendial assays.
  • Experience with or exposure to protein biologics method transfer, stability, formulation, process development, manufacturing, and/or cGMPs is a plus.
  • Adept at method troubleshooting.
  • Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Consistent analytical reasoning ability.
  • Solid technical writing skills.
  • Experience and familiarity with regulatory guidelines for method qualification/validation.
  • Experience in working with CDMOs/CROs.
  • Experience authoring regulatory sections for IND through BLA filings.
  • Proven interpersonal skills with the ability to work cooperatively as a member of a cross-functional team.

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.

#LI-PT1