The Clinical & Diagnostic Assay Development group within Pfizer Vaccines R & D is seeking an immunologist with experience in the development and implementation of influenza serological assays. The incumbent will serve as an expert on influenza assays and play a lead role in developing and implementing advanced serological assays for the clinical testing of Pfizer's influenza vaccine candidates. This includes helping to build-out a new influenza clinical testing laboratory (meeting GCLP and other regulatory requirements). As a group leader, this individual will oversee a team of junior scientists, manage the operations of the influenza testing lab, ensure business-critical deadlines are met, and communicate progress to senior leaders. The responsibilities also include clinical testing of human serum samples, and data review of clinical assay results. The incumbent will be part of a dynamic team and should possess a strong work ethic and collaborative spirit.
- Lead the development and qualification of influenza serological assays including micro neutralization (MNT), hemagglutination inhibition (HAI), and neuraminidase inhibition (NAI) assays, and others as needed
- Assist in the planning and build out of a new influenza clinical testing laboratory
- Design and execute assay qualifications and/or validations to support preclinical and clinical testing
- Write and review assay qualification protocols and reports, method SOPs
- Establish assays fit for preclinical and clinical testing including evaluation of long-term assay performance (e.g. QCS & proficiency panel data), sourcing and bridging critical reagents, and instrumentation IOQ/PQ
- Supervise activities of direct reports, provide scientific leadership, and foster teamwork, trust, and coaching among group members
- Execute testing of preclinical and clinical samples and meet program timelines
- Provide scientific strategy, analyze experimental data, draw conclusions, and propose future research plans
- Communicate experimental results at team meetings with group members and senior management
- Stay current on scientific and technical literature and attend relevant scientific meetings in order to apply new technologies and/or scientific principles
- Interact closely with groups including Viral Vaccines Research, Lab Automation/Robotics, Sample Management, Quality Assurance, Statistics, Research Informatics, and Project Management
- Apply GCLP guidelines to assay development and sample analysis, when required
- PhD with 0-4 years of relevant experience in academia or industry
- MS with 10+ years relevant industry experience
- Strong background in viral immunology and virology
- Subject matter expert in influenza serological assays and immune correlates of protection
- Familiarity with assay qualification/validation and system suitability/acceptance criteria, preferred but not required
- Experience working in high-throughput testing laboratories operating under GCLP guidelines, including SOPs, instrument IOQ/PQ, and good documentation practices, preferred but not required
- Demonstrated leadership ability through project management and mentoring
- Proven delivery of objectives in a complex matrix environment
- Ability to thrive in fast-paced, changing environment
- Excellent verbal and written communication skills
- Proficiency with Excel, PowerPoint, and statistical software including GraphPad Prism and/or JMP
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.
Other Job Details:
- Additional Location Information: Pearl River, NY
Eligible for Employee Referral Bonus
Eligible for Relocation Package
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.