1+ months

Principal Scientist, Biofunctional Assay Scientific Lead, Vaccine Research & Development

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

This position is within the Biofunctional Assay (BFA) area of the High Throughput Clinical Testing (HTCT) group within VRD. The incumbent will lead scientific aspects of biofunctional assays, and their routine performance assessments, used to support vaccine clinical studies and regularly liaise with the management of HTCT clinical testing coordination. The incumbent will be a technical expert in most biofunctional assays (ie, bacterial and virological), will lead/initiate investigations of assay performance, as well as plan exploratory/investigative assays and lead the interpretation of results from such assays, as needed. 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 BFA to determine & coordinate resource requirements (colleague, assay equipment and reagents) for biofunctional assays, to meet business timelines, as well as provide support to external contract lab(s). This position operates with limited supervision. Work and tasks managed are to be done in a compliant manner according to relevant SOP guidelines and GLP guidelines, when required.



**R** **OLE RESPONSIBILITIES**

Leads scientific aspects of biofunctional assays of used to support vaccine clinical studies. Be a technical expert on most biofunctional assays (bacteriological and virological) being developed or performed at any given time within BFA, and a recognized source of biofunctional assay information in cross-functional or program teams. Leads routine performance assessments (eg, QCS & proficiency panel data) of clinical assays performed in BFA. In addition, leads clinical and non-clinical BFA repeat code/assay failure assessments at the study level. Leads, initiates and performs biofunctional assay investigations and/or troubleshooting, based on these assessments, as needed. Presents updates of biofunctional assay assessments within HTCT and/or cross-functional and/or program teams (as required). Leads and plans biofunctional assay qualifications and/or validations. Regularly liaises with, and provide clinical testing strategy recommendations to, BFA clinical testing coordination management. Forecast and plan resource requirements for BFA clinical testing. Coordinates with other senior managers, project PI(s), and/or the head of BFA to plan/schedule BFA non-clinical tasks. Provide project related instructions as needed. Manages a team of up to 10 direct and indirect reports, and provides managerial guidance. Prepares and revises documents associated with biofunctional assays, including information/data archiving, SOP, technical reports and regulatory documents, as needed. Attends corporate, and departmental training, as available. Satisfactorily completes all cGLP, 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 (PhD) of experience. Strong verbal and written communication skills are required. A working understanding of biostatistics, as it applies to biofunctional assays, is a plus. Use of scientific reasoning skills to troubleshoot or improve assay performance, data systems and clinical process. Training in a cGLP environment and other international regulatory guidelines is preferred but not required



**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.



**\#LI-PFE**



**Other Job Details:**



+ Additional Location Information: Pearl River, NY

+ Eligible for Employee Referral Bonus

+ Eligible for relocation package



**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
Posted: 2019-09-26 Expires: 2020-03-20

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Principal Scientist, Biofunctional Assay Scientific Lead, Vaccine Research & Development

Pfizer
Pearl River, NY 10965

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