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
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EEO & Employment Eligibility
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Other Job Details:
- Additional Location Information: Pearl River, NY
Eligible for Employee Referral Bonus
Eligible for Relocation Package
N (Other) (United States of America)
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