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Small Molecule Clinical Assay Specialist, Manager


San Diego, CA
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Job Details

Job Title Small Molecule Clinical Assay Specialist, Manager

JobID 1046452-1852

Location: San Diego, CA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Scientific and operational oversight of clinical pharmacokinetic (PK), routine biomarker assays and bioanalyses conducted at external contract research organizations (CROs) and Pfizer internal laboratories.


*Lead and oversee clinical LC/MS based bioanalytical assay development /transfer, assay validation, bioanalysis, and troubleshooting of clinical PK and routine biomarker assays run at external CROs and internal laboratories. *Serve as the PK (and occasionally, biomarkers) assay representative on clinical teams ensuring effective management, communication, set up, budgeting, and delivery of program bioanalytical requirements, data, and reports.*Evaluate and review data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Pfizer standards and that data are meeting regulatory and scientific requirements.*Select, qualify, manage, and audit external CROs (located globally). *Assist in writing regulatory submissions and in responding to regulatory queries when needed. *Demonstrate ability to understand and interpret SOPs and Policies governing conduct of clinical trial, including Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and Good Clinical Practice (GCP) *Stay abreast of literature, regulatory guidances (including international regulations and guidances), industry best practices, White Papers, as appropriate, relevant to clinical bioanalysis to ensure practices are consistent with regulatory expectations and high scientific standards.


*Minimum BS degree in analytical chemistry/ chemistry or biology. *Previous experience performing and/or outsourcing LC/MS based bioanalysis. *Working knowledge of wide range of bioanalytical techniques based on chromatographic separation (e.g., HPLC/UPLC, various sample preparation techniques, and common mass spectrometry detection platforms, etc.). *Demonstrated understanding of global regulatory requirements including GLP, GCLP and the clinical trial process.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Limited travel for vendor audits and training (<5%).

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Small Molecule Clinical Assay Specialist, Manager*
*San Diego,California*

Apply on the Company Site

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