Principal Scientist

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Why Patients Need You Pfizers purpose is to deliver breakthroughs that change patients lives. Research and Development is at the heart of fulfilling Pfizers purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.ROLE SUMMARY As a Principal Scientist, you will be at the center of our operations and youll find that everything we do, every day, is in line with an unwavering commitment to quality. You will have the important role to generate high-quality immunoassay data in a regulated cGLP laboratory setting to support Pfizers vaccine programs according to Standard Operating Procedures. The High-throughput Clinical Immunoassays & Diagnostics (HCID) group within Pfizer Vaccines Research and Development is seeking a biologist with experience validating viral neutralization assays. As a Principal Scientist in the Neutralization Assay Group, the individual will be responsible primarily for generating high-quality bio-functional data in a regulated laboratory setting to support Pfizers Phase 3 vaccine programs. The candidate will function as a senior member of the Neutralization Assay Group and manage a small team of laboratory scientists. As an integral member of this dynamic team, the incumbent must have a strong work ethic and be highly collaborative with group members. All work is to be done in a compliant manner according to relevant SOP and GLP guidelines, when required. You will work with senior leadership to plan, design and critically analyze protocols to support the validation of assays as well as monitor assay performance and actively lead efforts in assay investigations. Additionally, the individual will author and review documentation to support the life cycle of the assay, including test methods and supporting documentation, and lead regulatory agency responses. You will manage Phase 3 clinical sample testing and associated assays, and oversee clinical testing-associated functions. You will be recognized as an influenza and bio-functional assay technical expert and a significant scientific contributor. With your deep knowledge as an influenza virologist, you will regularly contribute at the therapeutic area level and can represent the team on multidisciplinary teams. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will undertake mentoring activities to guide team members. As an expert, you will use your scientific acumen to validate HAI (hemagglutinin inhibition assay) bio-functional assays and address specific project requirements. Examples of collaboration efforts across multidisciplinary teams include Clinical & Diagnostic Assay Development, Cell Culture Team, Automation Group, Project Management, Quality Assurance, Research Informatics, and Statistics, as well as appropriate partner lines.ROLE RESPONSIBILITIES Responsible to drive the overall strategy for the influenza HAI assays, including leveraging a team of scientists to execute project goals and deliver compliant results according to program timelinesProvide clear, concise and timely responses to project team requests for experimental information, and guide and develop laboratory-based scientistsCommunicate experimental results at team meetings with group members and senior managementDesign strategy for the execution of clinical testing to meet program timelinesLead a team of junior scientists to execute project goalsAuthor and review documentation supporting the life cycle of the assay, including assay test methods, reagent qualifications, and other supportive documentationManage the preparation and qualification of new reagentsPerform experiments related to the optimization of bio-functional assaysProvide scientific input on experimental design and data analysisSupervise activities of direct reports, provide scientific leadership within the neutralization assay group, and foster teamwork, trust, and coaching among team membersProvide scientific strategy, analyze experimental data, draw conclusions, and propose future research plansSatisfactorily complete all cGLP training and safety training in conformance with departmental requirements.QUALIFICATIONS Must-Have MS with 10 years relevant industry experience, or a PhD with 4 years of experienceClassic virology experience, specifically with influenza based biofunctional assaysFamiliarity with assay validation and system suitability/acceptance criteriaExperience working in high-throughput clinical testing laboratories operating under GLP guidelines, including SOPs, instrument IOQ/PQ, and good documentation practicesDemonstrated leadership ability through project management and mentoringProven delivery of objectives in a complex matrix environmentAbility to thrive in fast-paced, changing environmentExcellent verbal and written communication skillsBreadth of knowledge of different areas of science, awareness of new technologies, and familiarity with current issues to apply novel and innovative approaches to problem solvingExcellent verbal and written communication skillsProficiency in the use of Word processing, Excel, PowerPoint, GraphPad and relevant scientific softwareNice-to-Have Experience with laboratory automation, including Hamilton automated liquid handling workstationsManagerial experience, preferably in a commercial research and development settingPHYSICAL/MENTAL REQUIREMENTSThe position has physical requirements of basic office and laboratory work (sitting, standing, and walking).Mental requirements include the ability to analyze data, design experiments, and present complex concepts to colleagues.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSWeekend work required to support mission critical projects, as needed.

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