Senior Scientist, Analytical Development

Zymeworks Inc.•Vancouver, BC

4d•CA$108,750 - CA$166,750

About The Position

This role is responsible for managing method development and phase-appropriate validation of methods at CDMOs for GMP biotherapeutic manufacturing. The Senior Scientist will serve as the Analytical Team Lead (ATL) and Subject Matter Expert (SME) for analytical method development and biochemical characterization across all phases of process development, from first-in-human to late-stage clinical and commercial filings. This includes supporting the development, establishment, and maintenance of analytical control strategies for multispecific antibodies and antibody-drug conjugate (ADC) biotherapeutics. The position requires collaboration with internal and external cross-functional teams, troubleshooting technical issues, and providing scientific guidance. The role also involves contributing to regulatory submissions (IND and BLA), authoring technical documents, and managing data from CDMO partners, ensuring all methods meet quality and regulatory requirements.

Requirements

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.
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.

Nice To Haves

Expertise in potency assay development and previous experience with translation of product mechanism of actions into robust QC release methods is highly preferred.

Responsibilities

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.