The role of the incumbent is to assist in the development and qualification of biofunctional assays to monitor the immune responses elicited by Pfizer’s vaccine candidates in phase 2/3 clinical studies. The incumbent will also be involved in the high-throughput clinical testing of human serum samples. This role will be responsible for managing 2-3 direct reports to perform clinical testing in the Neutralization Assay Group, primarily for the Toxin Neutralization Assay (TNA). As an integral member of this dynamic team, the incumbent must have a strong work ethic and be highly collaborative with the other group members. All work is to be done in a compliant manner according to relevant SOP guidelines and GLP and/or GCLP guidelines, when required.

ROLE RESPONSIBILITIES

• Perform biofunctional assays according to standard operating procedures (SOP) to support the TNA during phase 2 and 3 clinical studies using a robotic liquid handling workstation
• Execute testing of preclinical and clinical samples to meet program timelines
• Analyze the data derived from non-clinical assays to support reagent qualifications
• Update Labware Information Management System (LIMS) and Statistical Analysis Software (SAS) programs accordingly to requirement specifications to support TNA program as needed
• Train and qualify new analysts on different portions of the assay
• Support in updating and authoring documents including SOP, reagent reports, and data review
• Ensure the laboratory equipment are meeting company’s compliance guidelines including preventative maintenance and monthly calibrations.
• Assist in maintaining the laboratory, including ordering/ restocking supplies, updating reagent inventory, and ensuring cleanliness
• Satisfactorily complete all cGMP/GLP and safety training in conformance with Departmental requirements.Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements

QUALIFICATIONS

• B.S with at least 3+ years of laboratory experience; M.S degree preferred and 0-3 years of laboratory experience
• Experience managing direct reports
• Laboratory experience in biology, immunology, virology, and/or microbiology
• Familiarity with a biofunctional assay is a plus
• Experience handling infectious agents and biological materials safely, including C difficile toxins
• Robotic and automation experience preferred
• Experience following GLP guidelines, including adhering to SOPs, instrument IOQ/PQ, good documentation practices
• Proficiency with Microsoft Suite, including Word, Excel and PowerPoint. Comfortable using GraphPad Prism and JMP
• Good verbal and written communication skills

OTHER INFORMATION
• Eligible for employee referral bonus