Biologics & Immunogenicity Clinical Assay Manager

Pfizer Venezuela S.A

Base: $106,000.00 - $176,600.00; bonus/equity: 15....
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Pk and immunogenicity assay lifecycle management
Ligand binding methodologies (elisa and ecl)
Regulated bioanalysis of biologics
** Pfizer Venezuela S.A is seeking a Biologics & Immunogenicity Clinical Assay Manager to support drug development and post-marketing activities through oversight of bioanalytical assays and data management. The ideal candidate should possess extensive experience in bioanalytical methods, particularly in PK and immunogenicity assays, along with strong communication skills. **

Job Summary

  • The Biologics & Immunogenicity Clinical Assay Lead will play a critical role in supporting clinical strategies 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.
  • This position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.

Matching Summary

Match Score: 75

** Pfizer Venezuela S.A is seeking a Biologics & Immunogenicity Clinical Assay Manager to support drug development and post-marketing activities through oversight of bioanalytical assays and data management. The ideal candidate should possess extensive experience in bioanalytical methods, particularly in PK and immunogenicity assays, along with strong communication skills. **

Salary

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

Skills & Requirements

Must-have

  • PK and immunogenicity assay lifecycle management
  • Ligand binding methodologies (ELISA and ECL)
  • Regulated bioanalysis of Biologics
  • GxP regulations
  • Troubleshooting bioanalytical assays

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
  • Permanent work authorization in the United States

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter