Pfizer Manager, Large Molecule Clinical Assay Lead in Groton, Connecticut
The Clinical Assay Group (CAG) within the Clinical Pharmacology department is seeking a 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.
Minimum BS degree in biological sciences/analytical chemistry.
5-7 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: September, 1 2017
Eligible for Employee Referral Bonus
Locations: Groton CT, La Jolla CA, Cambridge MA
EEO & Employment Eligibility
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