1+ months

Principal Scientist

Pfizer
Pearl River, NY 10965
**ROLE SUMMARY**

This position is within the meningococcal clinical serum bactericidal assay (SBA) team of the High-throughput Clinical Immunoassays & Diagnostics (HCID) within Pfizer Vaccine research and Development (VRD). The incumbent will be a microbiologist experienced in meningococcal disease with knowledge of epidemiology, host-immune responses, disease mechanisms, serum bactericidal assay development, and meningococcal bacteria vaccine strategies. The incumbent will lead scientific aspects of SBA and their routine performance assessments, used to support vaccine clinical studies and regularly liaise with the management of HCID clinical testing coordination. The incumbent will lead/initiate investigations of assay performance, as well as plan exploratory/investigative assays and lead the interpretation of results from such assays. The incumbent is also expected to lead and plan biofunctional assay qualification and/or validation, as needed. In addition, the incumbent will work with the clinical throughput manager(s), project PI(s) and/or the head of the meningococcal clinical SBA team to determine & coordinate resource requirements (colleague, assay equipment and reagents) for clinical assays, to meet business timelines, as well as provide support to external contract laboratories. This position operates with limited supervision. Work and tasks managed are to be done in a compliant manner according to relevant SOP guidelines and GCLP practices.



**ROLE RESPONSIBILITIES**

Be a technical expert of serum bactericidal assays (SBAs) and a recognized subject matter expert for SBAs in cross-functional and program teams. Leads routine performance assessments (eg, quality controls and performance panel data) of clinical assays performed in HCID. Presents clinical throughput updates in HCID, cross-functional and program team meetings. Leads and plans clinical assay qualifications and/or validations. Develop and execute assay reagent qualification studies, establishing baseline reagent performance Monitor SBA performance during clinical throughput, and initiates investigations. Source reagents from vendors or in-house materials. Identifies additional vendors, as needed. Participates in evaluation of custom materials prepared under contract. Coordinate with other senior managers, project PI(s), and/or contract laboratories to plan/schedule reagent evaluations. Provide project related instructions as needed. Presents experimental results at group meetings, project meetings and Department meetings. Manage a team of 4 - 6 direct reports and provide managerial guidance. Prepare and revise documents associated with reagent qualifications, including test methods, operating procedures, technical reports and regulatory documents, as needed. Attend corporate and Departmental training, as available. Satisfactorily completes all GCLP, safety and other assigned training in conformance with job/departmental requirements.



**QUALIFICATIONS**



+ PhD in a scientific discipline such as immunology, microbiology, virology, biochemistry and/or bacteriology with at least 3 years (post-PhD) experience.

+ Knowledge and research experience and with Neisseria meningitidis and vaccine approaches to meningococcal disease is desired.

+ Strong verbal and written communication skills are required.

+ Use of scientific reasoning skills to troubleshoot or improve assay performance, data systems and clinical process.

+ Prior experience in high-throughput assays, such as opsonophagocytic assays, serum bactericidal assays, and multianalyte profiling platforms, such as the Luminex platform, is preferred but not required.

+ Training in a GCLP environment and other international regulatory guidelines is preferred but not required.



OTHER INFORMATION

Relocation eligible

Eligible for employee referral bonus



**\#LI-PFE**



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**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.



Research and Development

Categories

Posted: 2020-10-13 Expires: 2020-12-12

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Principal Scientist

Pfizer
Pearl River, NY 10965

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