1+ months

Director of Biofunctional Assay Group, Vaccine Research Division

Pearl River, NY 10965

The purpose of this position is to oversee and manage Biofunctional Assay (BFA) group within High Throughput Clinical Testing (HTCT). This position includes: (i) organization and managerial oversight of the development and qualification/validation of biofunctional assays to support immunogenicity assessments of designated advanced phase (typically, but not exclusively, post-PoC) VRD programs; (ii) organization and managerial oversight of throughputing of clinical study samples in the qualified/validated assays, as assigned; (iii) assuring appropriate levels of GLP compliance, including documentation, specimen/data tracking and validation, to ensure that the quality of data meets regulatory expectations and that laboratory operations will meet the rigors of internal and external audits; and (iv) maintaining and promoting laboratory safety at all times and efforts toward GMP compliance. The incumbent will also be an active member of VRD cross-functional teams, including serology subteams and/or program teams, as appropriate and assigned.


+ Oversees and manages the timely and efficient development, qualification/validation, and/or throughput of biofunctional assays, including, but not limited to, serum bactericidal assays, opsonophagocytic assays, toxin neutralization assays and virus neutralization assays, which are needed to support VRD programs (typically, but not exclusively, post-PoC).

+ Actively participates in VRD cross-functional teams, including serology subteams and program teams, as appropriate and assigned, to set and support project strategies and to ensure the timely completion of testing of clinical samples according to quality standards required by internal and external regulatory and quality assurance units.Participate in, and contribute to, the development of strategies, reports and other support documents as needed to meet regulatory requirements.

+ Manages the BFA group colleagues, especially direct reports, setting their annual objectives and collaborating with them to create development plans. Conduct regular performance discussions, ensuring their desired/mandates training/development and retention of talent. Conduct year-end performance appraisals and nominate deserving candidates for promotions. Provide input at HTCT staff and department meetings, as well as year-end rating calibration meetings.

+ Coordinates and prioritizes BFA group efforts between other HTCT functional areas and VRD departments (ie, Research and CDAD), as needed.Participate in scientific discussion with colleagues through internal meetings journal clubs and formal scientific seminars.

+ Ensures that BFA assays, tasks and activities are performed safely, and BFA regulated tasks / activities are performed in compliance with cGMP/GLP and Pfizer / Regulatory agency requirements.

+ Guides and/or directs BFA staff as to priorities of projects, appropriate methodologies, and proper interpretation of biofunctional assay data.

+ Manages a team of approximately 40-60 direct and indirect reports; and provides managerial guidance.

+ Satisfactorily completes all cGMP/GLP and safety training in conformance with VRD requirements.

+ Perform other duties as assigned.


PhD in a scientific discipline such as immunology, microbiology, virology, bacteriology or biochemistry with at least 10 years (PhD) of experience. Strong verbal and written communication skills are required.

**Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.**


Prior managerial experience in an assay developmental or high throughput setting is preferred. A working understanding of assay qualification and validation, as well as biostatistics, as it applies to biofunctional assays, is a plus. Prior experience troubleshooting or improving assay performance, electronic data systems and assay processes is preferred. Training in a cGLP environment and other international regulatory guidelines is a plus.

**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 ommonly 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.


**Other Job Details:**

+ Additional Location Information: Pearl River, NY

+ Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


Posted: 2019-08-16 Expires: 2020-01-03

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Director of Biofunctional Assay Group, Vaccine Research Division

Pearl River, NY 10965

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