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.
- 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
- 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
• Eligible for employee referral bonus
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.