Principal Scientist, Influenza Bio-Functional Assay Scientist

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Job description

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's 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 you'll 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 Pfizer's 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 Pfizer's 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 timelines

• Provide clear, concise and timely responses to project team requests for experimental information, and guide and develop laboratory-based scientists

• Communicate experimental results at team meetings with group members and senior management

• Design strategy for the execution of clinical testing to meet program timelines

• Lead a team of junior scientists to execute project goals

• Author and review documentation supporting the life cycle of the assay, including assay test methods, reagent qualifications, and other supportive documentation

• Manage the preparation and qualification of new reagents

• Perform experiments related to the optimization of bio-functional assays

• Provide scientific input on experimental design and data analysis

• Supervise activities of direct reports, provide scientific leadership within the neutralization assay group, and foster teamwork, trust, and coaching among team members

• Provide scientific strategy, analyze experimental data, draw conclusions, and propose future research plans

• Satisfactorily complete all cGLP training and safety training in conformance with departmental requirements.

QUALIFICATIONSMust-Have

• MS with 10+ years relevant industry experience, or a PhD with 4+ years of experience

• Classic virology experience, specifically with influenza based biofunctional assays

• Familiarity with assay validation and system suitability/acceptance criteria

• Experience working in high-throughput clinical testing laboratories operating under GLP guidelines, including SOPs, instrument IOQ/PQ, and good documentation practices

• 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

• Breadth of knowledge of different areas of science, awareness of new technologies, and familiarity with current issues to apply novel and innovative approaches to problem solving

• Excellent verbal and written communication skills

• Proficiency in the use of Word processing, Excel, PowerPoint, GraphPad and relevant scientific software

Nice-to-Have

• Experience with laboratory automation, including Hamilton automated liquid handling workstations

• Managerial experience, preferably in a commercial research and development setting

PHYSICAL/MENTAL REQUIREMENTS

The 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 REQUIREMENTS

Weekend work required to support mission critical projects, as needed.

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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.

Research and Development