Pfizer Senior Manager, Large Molecule Clinical Assay Specialist in Groton, Connecticut
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.
The Clinical Assay Group (CAG) within the Clinical Pharmacology department is seeking an experienced large molecule bioanaltyical scientist to lead scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA and Nab), and soluble target assays and bioanalyses conducted at external contract research organizations (CROs) or in collaboration with internal laboratories. This role requires strong communication, ability to work in a fast paced global matrixed environment, ability to handle complex processes and tasks, and hands on experience in design, review, and execution of ligand binding (ELISA, ECL) and cell based assays. In this role, the successful candidate will:
Lead and oversee assay transfer/development, assay validation, bioanalysis, and troubleshooting of clinical PK, immunogenicity, and soluble target assays conducted 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 bioanalytical data and reports within expected timelines.
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 relevant regulatory queries.
Stay abreast of bioanalytical science, new technologies, regulations, and SOPs/internal guidances to ensure compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and regulatory expectations.
Influence internal and external environment through scientific presentations/publications, Clinical Assay initiatives and sub-teams, and cross line initiatives and sub-teams.
Minimum BS degree in biological sciences/analytical chemistry.
7 years relevant experience performing and/or outsourcing regulated 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.
- Limited travel for vendor audits, conferences, and training (5%).
ADDITIONAL OFFER DETAILS
Last Date to Apply for Job: December 31,2017
This job is Pfizer Exempt US Grade 011
Additional Location Information: Groton CT, La Jolla CA, Cambridge MA (Technology Square)
Eligible for Employee Referral Bonus
EEO & Employment Eligibility
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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.