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Senior Associate Scientist - High-throughput Clinical Immunoassays & Diagnostics

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
Jun 17, 2021

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Sector
Science, Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
ROLE SUMMARY

The role of the incumbent is to assist in the execution and oversight of clinical testing of biofunctional assays to monitor the immune responses elicited by Pfizer's vaccine candidates in phase 3 clinical studies. The incumbent will oversee the training and qualification of new analysts, monitor clinical testing progress, and monitor assay performance for viral programs within the Neutralization Assay Group. As an integral member of this dynamic team, the incumbent must have a strong work ethic and be highly collaborative with the other group members. All work is to be done in a compliant manner according to relevant SOP guidelines and GLP and/or GCLP guidelines, when required.

ROLE RESPONSIBILITIES
  • Perform biofunctional assays according to standard operating procedures (SOP) to support viral and bacterial programs for phase 3 clinical studies using a robotic liquid handling workstation
  • Execute testing of preclinical and clinical samples to meet program timelines
  • Analyze the data derived from non-clinical assays to support reagent qualifications
  • Update Labware Information Management System (LIMS) and Statistical Analysis Software (SAS) programs accordingly to requirement specifications to support the Neutralization Assay Group as needed
  • Train and qualify new analysts according to assay SOP
  • Support in updating and authoring documents including SOP, reagent reports, and data review
  • Ensure the laboratory equipment are meeting company's compliance guidelines including preventative maintenance and monthly calibrations.
  • Assist in maintaining the laboratory, including ordering/ restocking supplies, updating reagent inventory, and ensuring cleanliness
  • Satisfactorily complete all cGMP/GLP and safety training in conformance with Departmental requirements. Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements


QUALIFICATIONS
  • M.S. with at least 2 years or a B.S with at least 4 years of laboratory experience
  • Laboratory experience in biology, immunology, virology, and/or microbiology
  • Familiarity with a biofunctional assay is a plus
  • Experience handling infectious agents and biological materials safely, including C difficile toxins and live BSL-2 virus
  • Robotic and automation experience
  • Experience following GLP guidelines, including adhering to SOPs, instrument IOQ/PQ, good documentation practices
  • Proficiency with Microsoft Suite, including Word, Excel and PowerPoint. Comfortable using GraphPad Prism
  • Good verbal and written communication skills


PHYSICAL/MENTAL REQUIREMENTS

The position has physical requirements of basic office and laboratory work (sitting, standing, and walking).

Other Job Details:
  • Eligible for employee referral programs: YES
  • Eligible for relocation support: YES

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    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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