Senior Scientist, Analytical Development

Socket.dev; West Vancouver; On-site; CAD 120,000 - 160,000; Full time

Benefits offered by this job

Vacation & PTO

Medical benefits

RRSP / Pension matching

Employee equity program

Volunteer time off

Job summary

Zymeworks is seeking an Analytical Team Lead to advance method development and validation for GMP biotherapeutics, including multispecific antibodies and ADCs.

You will collaborate with R&D, Process Development, Manufacturing, Quality, and Regulatory teams, author regulatory sections, and guide CDMO partners in this role.

Qualifications

• Ph.D. in biochemistry, cell biology, analytical science, or related field with 5+ years in pharma/biotech.
• Experience with analytical chromatography, capillary electrophoresis, ELISA, cell-based bioassays, protein MS, and biophysical methods.
• Expertise in potency assay development and translation of MOA into QC release methods.
• Knowledge of biotech product development and analytical expectations across clinical stages.
• Excellent oral and written communication skills.
• Familiarity with regulatory guidelines for method qualification/validation and regulatory sections for IND–BLA.
• Ability to work with third-party CDMO networks.
• Champion Zymeworks values: Act with Integrity. Collaborate. Care.
• Adherence to high professional standards and confidentiality.

Responsibilities

• Lead method development and validation at CDMOs for GMP biotherapeutics.
• Serve as Analytical Team Lead (ATL) and SME for analytical method development and characterization.
• Support analytical control strategies for multispecific antibodies and ADCs.
• Collaborate with cross-functional teams (R&D, Process Development, Manufacturing, Clinical, Quality, Regulatory).
• Troubleshoot complex technical issues and advise team members and CDMOs.
• Contribute to CMC sections of IND and BLA submissions.
• Author technical documents and present to management and project groups.
• Organize and analyze internal CDMO data and reports.
• Ensure methods meet quality and regulatory requirements.
• Maintain positive relationships with peers, management, and external partners.

Skills

Analytical chromatography

Capillary electrophoresis

ELISA

Cell-based bioassays

Protein mass spectrometry

Biophysical methods

Potency assays

Regulatory familiarity

Education

Ph.D. in biochemistry / related field

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.