Biologics & Immunogenicity Clinical Assay Manager

pfizer.ca

Base: $106,000.00 - $176,600.00; bonus/equity: 15....
Hybrid
Pk and immunogenicity assay lifecycle management
Large molecule pk and immunogenicity
Regulated bioanalysis of biologics
Pfizer is seeking a Biologics & Immunogenicity Clinical Assay Manager to support clinical strategies in drug development and post-marketing activities. The role involves oversight of bioanalytical assays, regulatory compliance, and collaboration with internal and external partners

Job Summary

  • The Biologics & Immunogenicity Clinical Assay Lead will support clinical strategies through scientific and technical support, oversight and management of external and internal partners involved in delivering quality, timely, and regulatory compliant PK and immunogenicity bioanalytical assays and data.
  • Leads and oversees large molecule PK and immunogenicity (ADA and Nab) assay lifecycle management from early stage to registration encompassing executing analytical strategy, development and method design, validation, data quality review, corresponding sample analyses & reporting to meet evolving program objectives and regulatory expectations.
  • The annual base salary for this position ranges from $106,000.00 to $176,600.00, in addition to eligibility for a bonus target of 15.0% and a share-based long-term incentive program, along with comprehensive benefits.

Matching Summary

Match Score: 85

Pfizer is seeking a Biologics & Immunogenicity Clinical Assay Manager to support clinical strategies in drug development and post-marketing activities. The role involves oversight of bioanalytical assays, regulatory compliance, and collaboration with internal and external partners.

Salary

Base: $106,000.00 - $176,600.00; Bonus/Equity: 15.0% bonus target; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • PK and immunogenicity assay lifecycle management
  • large molecule PK and immunogenicity
  • regulated bioanalysis of Biologics
  • ligand binding methodologies
  • GxP regulations governing clinical trials

Nice-to-have

  • CRO management and outsourcing experience
  • regulatory inspections experience
  • clinical trial design understanding
  • mentoring or managing colleagues
  • LC/MS quantitation of large molecules

Key Requirements

  • PhD or equivalent with <2 years experience
  • BS with 5-6 years experience
  • MS with 3-5 years experience
  • Minimum 5+ years industry/bioanalytical experience
  • Working knowledge of GxP regulations
  • Permanent work authorization in the United States

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter