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 diagnostic assays to direct assay development, technology transfer, and clinical testing activities that align with programmatic goals. The incumbent is also expected to apply their skills in assay development to support assay lifecycle management of multiple clinical diagnostic assays that support vaccine pre-clinical and clinical studies. The position will lead multiple managers whom may have oversight of various types of previously developed 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. 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.
•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.
•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.
•Quality: Ensure that Pfizer’s values are reflected on a continuous basis in day-to-day job functions. Performs other duties as assigned.