Biologics & Immunogenicity Clinical Assay Manager
Pfizer
full-time
Posted on:
Location Type: Office
Location: La Jolla • California • Connecticut • United States
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Salary
💰 $106,000 - $176,600 per year
About the role
- Serves as a member of the clinical study team and bioanalytical subject matter expert for executing clinical study setup & conduct
- Contributing to the study protocol development & review
- Preparing submissions and addressing regulatory queries
- Implementing bioanalytical strategies & assays
- Delivering regulatory compliant data and reports within program timelines
- Leads and oversees large molecule PK and immunogenicity (ADA and Nab) assay lifecycle management
- Assists CROs with effective troubleshooting of the bioanalytical assay and issue resolution
- Functions as key point of contact with external & internal laboratories
- Supports the clinical trial conduct within scope of the Clinical Bioanalytics responsibilities
- Contributes to the development of Best Practices, processes, templates, and policies
- Maintains up-to-date knowledge of current and novel ligand binding technologies & techniques, global regulatory guidance & expectations, and industry best practices
Requirements
- PhD or equivalent in biology or analytical chemistry/chemistry with <2 years of experience
- B.S. with 5 to 6 years of relevant industry experience OR M.S with 3 to 5 years of relevant experience
- Minimum of 5+ years of industry or bioanalytical experience with PK and/or immunogenicity assay development, validation, and sample analyses ligand binding (ELISA and ECL) methodologies
- Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidance and expectations relevant to regulated bioanalysis
- In depth knowledge in regulated bioanalysis of Biologics and Immunogenicity
- Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously
- Highly effective communication skills: verbal, written, and presentation.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
bioanalytical strategiesassay developmentassay validationsample analysesligand binding methodologiesELISAECLPK analysisimmunogenicityregulatory compliance
Soft Skills
strategic thinkingproject managementcommunicationproblem-solvingcollaborationleadershiptroubleshootingadaptabilityorganizational skillspresentation skills
Certifications
PhD in biologyPhD in analytical chemistryM.S. in relevant fieldB.S. in relevant field