Pfizer Large Molecule Clinical Assay Specialist, Senior Manager in Groton, Connecticut

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.

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

• Minimum BS degree in biological sciences/analytical chemistry.

• Previous experience performing and/or outsourcing large molecule bioanalysis.

• Working knowledge of wide range of large molecule bioanalytical techniques (e.g., ELISA, ECL, Gyros, FACS, RIA etc).

• Demonstrated understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

• Lead and oversee assay transfer/development, assay validation, bioanalysis, and troubleshooting of clinical PK, immunogenicity, and routine biomarker assays run at external CROs and internal laboratories.

• Serve as the PK and ADA assay representative on clinical teams ensuring effective management, communication, set up, budgeting, and delivery of program bioanalytical requirements, data, and reports.

• Evaluate and review raw 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 of the required quality (regulatory and scientific).

• Select, qualify, manage, and audit external CROs located globally.

• Assist in writing regulatory submissions and in responding to regulatory queries when needed.

• Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.

• Influence internal and external environment through scientific presentations/publications, Clinical Assay initiatives and sub-teams, and cross line initiatives and sub-teams.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited travel for vendor audits and training (

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.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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.