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Principal Scientist, Late-Stage Bio-functional Assay Scientist, Vaccines

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
Jun 28, 2022

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Discipline
Physical Sciences, Chemistry, Health Sciences, Vaccine Research
Position Type
Full Time
Job Type
Staff Scientist
Organization Type
Pharma
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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 validating viral neutralization assays. As a Principal Scientist in the Neutralization Assay Group, the individual will be responsible primarily for generating high-quality biofunctional 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. The individual 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 biofunctional 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 viral or bacterial assay validation activities, including leveraging 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 biofunctional 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
  • 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

BASIC QUALIFICATIONS
  • MS with 10+ years relevant industry experience, or a PhD with 4+ years of experience
  • Strong background in immunology, microbiology, virology, and/or bacteriology is essential
  • Familiarity with assay qualification/validation and system suitability/acceptance criteria
  • Experience working in high-throughput 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


PREFERRED QUALIFICATIONS
  • Classic virology or microbiology experience, with biofunctional assays preferred, but not required
  • Experience with laboratory automation, including Hamilton automated liquid handling workstations
  • Managerial experience within a regulated environment
  • Experience within an industry setting preferred, but not required


OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

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
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