This is a senior position within the Clinical and Diagnostic Assay Development group within Pfizer's Vaccine Research and Development. The incumbent applies their expertise and in-depth knowledge of assay development to lead in the design, development, qualification, and validation of various clinical and diagnostic assays, with emphasis on molecular based assays, to support vaccine pre-clinical, clinical and efficacy studies. 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 internal and regulatory documents. The incumbent is also responsible for facilitating communication and technology transfer between the assay development group and the clinical testing group. 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 • Oversee the design, development, qualification and validation of molecular based assay in support of pre-clinical and clinical trials. • Collaborate as necessary with the appropriate leaders/scientists within Vaccine Research and Development to determine and communicate the nature of assays to develop. Interact with intra and interdepartmental personnel in scientific discussions for assay development or improvements. • Write and review reports, technical documents and presentations to support assay development, qualification, validation and transfer. • Supervises assigned staff and/or any laboratory staff. Ensures that the incumbent and staff have received appropriate training and that the training is current. • Provide work assignments to direct reports 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 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. QUALIFICATIONS • PhD in Immunology or related field • >10 years of post-graduate experience (preferably in industry) • A strong background in immunology, molecular biology and assay development is required Expertise in development of molecular based assays / diagnostic assays required • Experience of interacting with regulatory agencies is desired. • 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 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. 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. Relocation Eligible: YES Grade: 013 Last Date to Apply for Job: open A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.