Senior Scientist, Analytical Development

Job description

What You'll Do Manage the method development and phase-appropriate validation of methods at CDMOs for GMP biotherapeutic manufacturing. Serve as Analytical Team Lead (ATL) and Subject Matter Expert (SME) for analytical method development and biochemical characterization for all phases of process development from first-in-human to late-stage clinical and commercial filings. Support developing, establishing, and actively maintaining analytical control strategies for multispecific antibodies and antibody-drug conjugate (ADC) biotherapeutics. Collaborate productively within internal and external cross-functional teams (Research, Process Development, Manufacturing, Clinical, Quality, Regulatory) and provide analytical expertise for biotherapeutics including ADCs. Troubleshoot complex technical issues and provide scientific guidance to team members and/or contract laboratories. Contribute to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA). Author technical documents and deliver presentations to management, technical, and project groups. Organize, maintain, and analyze internal archive of data and reports generated by CDMO partners. Ensure that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines, and procedures. Establish and maintain positive working relationships with peers, management, and external partners. What You'll Bring Ph.D. in biochemistry, cell biology, analytical science, or related field and a minimum of 5 years of applicable experience in the pharmaceutical or biotechnology field. An equivalent combination of education and experience may be considered. Extensive experience with analytical chromatography, capillary electrophoresis, ELISA, cell-based bioassays, protein mass spectrometry, biophysical methods, and other analytical techniques. Expertise in potency assay development and previous experience with translation of product mechanism of actions into robust QC release methods is highly preferred. Extensive knowledge of biotechnology product development and analytical expectations at each stage of clinical product development life-cycle. Excellent oral and writing skills. Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings. Demonstrated ability to independently conduct research and development activities in collaboration with a third party CDMO network. Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care. Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion. Total Rewards We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies. The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience). Our total rewards package that includes: Industry leading vacation and paid time off Exceptional medical, dental and vision benefits by country Zymelife health and wellness benefits Matching RRSP / 401K / Pension program Employee Share Purchase Program Employee Equity Program Paid time off to volunteer in your community This role is not eligible for relocation or immigration support. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability. NOTE TO AGENCIES: Zymeworks values our relationships with our recruiting partners. We only accept resumes from those partners who have been contracted with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract. Company Description Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the early-stage development of innovative medicines. We are a global company headquartered in Vancouver BC, with operations in Bellevue WA, Dublin IRE, and Singapore. Why Work With Us Nothing is more critical to our success than the quality of our team. The work we do is meaningful and impactful - we care about each other as well as the patients we serve. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. This role will be located in Bellevue, WA or Vancouver, BC and is hybrid with a minimum of 3 days per week onsite.