Biologics & Immunogenicity Clinical Assay Manager

pfizer.hu

Base: $106,000.00 - $176,600.00; bonus/equity: 15....
Hybrid
Pk and immunogenicity assay lifecycle management
Large molecule pk and immunogenicity
Ligand binding methodologies
Pfizer is seeking a Biologics & Immunogenicity Clinical Assay Manager to support clinical strategies in drug development and post-marketing activities. The ideal candidate will have a strong background in bioanalytical methods, particularly with large molecule pharmacokinetics and immunogenicity assays, along with excellent communication skills

Job Summary

  • Play a critical role in supporting clinical strategies in all stages of drug development and post marketing activities through scientific and technical support, oversight and management of external and internal partners.
  • 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.
  • We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

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 ideal candidate will have a strong background in bioanalytical methods, particularly with large molecule pharmacokinetics and immunogenicity assays, along with excellent communication skills.

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
  • ligand binding methodologies
  • GxP regulations
  • regulated bioanalysis of Biologics

Nice-to-have

  • CRO management and outsourcing experience
  • regulatory inspections experience
  • clinical trial design understanding
  • training, mentoring, or managing colleagues

Key Requirements

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

Work Rights

Permanent work authorization required

Tailored Resume

Cover Letter