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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.
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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
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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.
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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