Principal Scientist, Neutralization Assay Group

**Relocation support available**

Pfizer’s Vaccine Research and Development organization has been at the forefront of making history and improving human health – including creating some of the most complex and most sophisticated vaccines in the world, designed to tackle a wide range of infectious diseases of large unmet medical needs in people of all ages.

Role Summary

The High-throughput Clinical Immunoassays & Diagnostics (HCID) group within Pfizer Vaccines Research and Development is seeking a biologist with experience designing and trouble-shooting neutralization and bio-functional assays. 

As a Principal Scientist in the Viral Bio-functional Assays Group, you will be responsible primarily for generating high-quality bio-functional data in a regulated laboratory setting to support Pfizer’s Phase 3 vaccine programs. 

You will be a senior member of this group in a leadership role. Management responsibilities include managing a 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. This role will author and review documentation to support the life cycle of the assay, including reagent qualification reports, responses with regulatory agencies, and internal and external presentations. 

The responsibilities also include reviewing clinical data and quality control data to monitor assay performance. As an expert, you will use your scientific acumen to validate 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
• -Manage a viral assay to support late-stage clinical testing, including managing a team of scientists to execute project goals and deliver compliant results according to program timelines
• -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
• -Support ongoing clinical testing, including troubleshooting technical issues andaddressing queries from regulatory agencies
• -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
• -Communicate experimental results at team meetings with group members and senior management
• -Promote the use of novel experimental approaches within therapeutic area; routinely investigate/create innovative processes, hypotheses, and methodologies.
• -Stay current on scientific and technical literature plus attend relevant scientific meetings to apply new technologies and/or scientific principles
• -Participate and organize cross-functional team meetings

Qualifications and Basic Qualifications

Must-Have

• -MS with 10+ years relevant industry experience, or a PhD scientist with post-doctoral experience contributing to 4+ years of experience
• -Strong background in virology, immunology, and/or microbiology is essential
• -Familiarity with the process of bio-functional assay validation preferred, but not required
• -Experience working in 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

Nice-to-Have

• -Classic virology, immunology, or microbiology expertise
• -Experience with laboratory automation, including Hamilton automated liquid handling workstations
• -Managerial experience, preferably in a commercial research and development setting with 3-5 direct reports
• -Experience within an industry setting, including a start-up company, or mid-size biotech/pharma

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• -This position may require occasional weekend and evening work to meet critical business timelines.
• -This position may require occasional travel between Pfizer sites and other business-related travel.

Work Location Assignment: On Premise