This is a senior position within the Clinical and Diagnostic Assay Development group within Pfizer's Vaccine Research and Development. Reporting to the Head of Serology and Diagnostic Assay Development, the incumbent applies their expertise in immunological, molecular, serological, and other diagnostic assays (often referred to as devices) to direct assay development, technology transfer, clinical testing activities supportive of programmatic goals, and design experiments to answer various programmatic research questions. The incumbent is also expected to apply their skills in assay development to support lifecycle management of multiple clinical diagnostic assays that support vaccine pre-clinical and clinical studies. The position will lead or influence multiple managers whom may have oversight of various types of assays ready for use in pre-clinical or clinical studies (molecular, immuno, or toxicological detection assays).
In addition to these activities the incumbent may be a member of program teams and applies technical/scientific expertise to contribute / resolve issues regarding the preclinical components of various assay-related documents. This may involve presenting of assay development, root cause analysis, and/or assay trending results and proposals to senior leaders within Vaccine Research and Development. The incumbent is also responsible for facilitating assay transfers between assay development teams and clinical testing groups which may be internal or external to Pfizer. In addition, design of assays to support research relevant to various vaccine programs is an expected job function; as well as, assuming an assay development lead role for various vaccine programs. The incumbent is accountable to line / senior management and project leadership. All work is to be done in a compliant manner according to relevant SOP guidelines and GCLP and/or CGMP guidelines, when required.ROLE RESPONSIBILITIES
•Sets objectives for and manages multiple diagnostic assay development projects. These may include serological, immuno, molecular, and/or toxicological diagnostic tests.
•Collaborate as necessary with the appropriate leaders/scientists within Vaccine Research and Development to determine types of diagnostic assays to develop.
- Interact with intra- and interdepartmental personnel in scientific discussions for assay development or improvements. The incumbent may also to lead or support external collaborations and/or technology transfers.
- Directly manage or support non-clinical and clinical testing with specific assays
- Functional assay subject matter expert throughout assay lifecycle
- Author publications relevant to the work being performed
•Write and review reports, technical documents and presentations to support assay development, qualification, validation and transfer to high throughput clinical testing teams.
•Supervises laboratory staff and other Managers. Ensures that the incumbent and staff have received appropriate training and that the training is current.
•Provide work assignments to teams on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
•Keep abreast of new scientific/ technology development by participating in scientific meetings/ seminars and through regular scientific review.
•Present scientific findings and developed technologies in meetings and publish relevant articles in scientific journals.
•Participate and lead in developing new diagnostic-based technologies and establishing those technologies to characterize vaccines.
- Interact with various multidisciplinary vaccine program teams as a Development Assay Lead (DAL)
- Interact, coordinate, and advise other assay development groups outside immediate line management on program related assay needs
- Drive assay development from both within and outside teams, through collaboration, to meet programmatic timelines
Quality: Ensure that Pfizer's values are reflected on a continuous basis in day-to-day job functions. Performs other duties as assigned.QUALIFICATIONS
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.
OTHER JOB DETAILS
- PhD in Immunology or related field
- 10 -15 years of post-graduate experience (preferably in industry)
- A strong background in Immunology and Molecular assay development is required
- Experience with vaccine studies
- A background with primary authored publications is required
- Expertise in development of diagnostic assays required
- Strong verbal and written communication skills are required
- Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is required
- Experience in managing scientists is desired
- Experience of interacting with regulatory agencies is desired.
Eligible for Relocation Package
Eligible for Employee Referral Bonus Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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