Zymeworks Inc.
Associate Scientist, Clinical Bioanalysis
Zymeworks Inc., Redwood City, California, United States, 94061
Overview
Associate Scientist, Clinical Bioanalysis at Zymeworks Inc. Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biotechnology company 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. We are a global company headquartered in Vancouver, BC, with operations in Bellevue, WA, Dublin, Ireland, Singapore and Redwood City, CA.
Location: Vancouver BC, Bellevue WA, or Redwood City CA. This role is hybrid with a minimum of 3 days per week onsite.
Responsibilities
Design bioanalytical methods to evaluate PK and immunogenicity to support late-stage preclinical and all stages of clinical development for Zymeworks’ portfolio of multispecific antibodies and ADCs.
Oversee and manage bioanalytical method transfer, assay development and validation at contract research organizations (CROs).
Design, oversee and manage critical reagent generation campaigns at CROs.
Manage in-house and CRO critical reagent inventory and lifecycle management.
Ensure bioanalytical work performed at CROs aligns with regulatory guidance and meets program scientific needs.
Collaborate with cross-functional teams to design assays and contribute to strategy for multispecific antibodies and ADCs.
Write and review regulatory and scientific documentation including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans and Clinical Study Reports.
Review/author scientific publications, abstracts, posters; maintain knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis and biopharmaceutics.
Present results to supervisors and project teams, verbally and in written reports or presentations.
Perform other duties as assigned.
Qualifications
PhD or equivalent in Pharmacology, Biomedicine, Biochemistry or related field with 1-3 years of relevant pharmaceutical/ CRO/ clinical research experience.
Hands-on experience with large molecule PK and ADA bioanalytical method development and validation.
Experience managing bioanalytical work and reagent generation campaigns at CROs is highly desirable.
Experience performing PK studies and data analysis (e.g., WinNonlin) in a drug development setting is an asset.
Strong collaboration and interpersonal skills; ability to work in cross-functional teams.
Advanced spreadsheet and strong scientific writing skills; ability to manage multiple projects and meet deadlines.
Total Rewards We offer a comprehensive total rewards package, including competitive salaries, benefits, and opportunities for professional growth. The base salary range shown reflects the minimum and maximum target for new hire salaries for the location of the posting and does not include bonus, equity, or benefits. Individual pay is determined by location and qualifications.
Industry-leading vacation and paid time off
Medical, dental and vision benefits by country
Health and wellness benefits
Matching retirement program
Employee Share Purchase Program and Equity Program
Volunteer time off
This role is not eligible for relocation or immigration support. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin or disability.
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Location: Vancouver BC, Bellevue WA, or Redwood City CA. This role is hybrid with a minimum of 3 days per week onsite.
Responsibilities
Design bioanalytical methods to evaluate PK and immunogenicity to support late-stage preclinical and all stages of clinical development for Zymeworks’ portfolio of multispecific antibodies and ADCs.
Oversee and manage bioanalytical method transfer, assay development and validation at contract research organizations (CROs).
Design, oversee and manage critical reagent generation campaigns at CROs.
Manage in-house and CRO critical reagent inventory and lifecycle management.
Ensure bioanalytical work performed at CROs aligns with regulatory guidance and meets program scientific needs.
Collaborate with cross-functional teams to design assays and contribute to strategy for multispecific antibodies and ADCs.
Write and review regulatory and scientific documentation including Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans and Clinical Study Reports.
Review/author scientific publications, abstracts, posters; maintain knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis and biopharmaceutics.
Present results to supervisors and project teams, verbally and in written reports or presentations.
Perform other duties as assigned.
Qualifications
PhD or equivalent in Pharmacology, Biomedicine, Biochemistry or related field with 1-3 years of relevant pharmaceutical/ CRO/ clinical research experience.
Hands-on experience with large molecule PK and ADA bioanalytical method development and validation.
Experience managing bioanalytical work and reagent generation campaigns at CROs is highly desirable.
Experience performing PK studies and data analysis (e.g., WinNonlin) in a drug development setting is an asset.
Strong collaboration and interpersonal skills; ability to work in cross-functional teams.
Advanced spreadsheet and strong scientific writing skills; ability to manage multiple projects and meet deadlines.
Total Rewards We offer a comprehensive total rewards package, including competitive salaries, benefits, and opportunities for professional growth. The base salary range shown reflects the minimum and maximum target for new hire salaries for the location of the posting and does not include bonus, equity, or benefits. Individual pay is determined by location and qualifications.
Industry-leading vacation and paid time off
Medical, dental and vision benefits by country
Health and wellness benefits
Matching retirement program
Employee Share Purchase Program and Equity Program
Volunteer time off
This role is not eligible for relocation or immigration support. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin or disability.
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