Principal Scientist, Clinical Testing & Business Operations - Pearl River

Employment Type

: Full-Time

Industry

: Scientific Research



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ROLE SUMMARY

This position is within the Reagents area of the High Throughput Clinical Testing (HTCT) group of Clinical Testing & Business Operations within VRD. The incumbent will oversee critical reagent identification and qualification for biofunctional and ligand-binding assays supporting various vaccine development projects. In addition, the incumbent will work with the clinical throughput manager(s), project PI(s) and the head of Reagents to plan and prioritize and coordinate reagent qualification, as well as forecast resources for these tasks, in order to meet business timelines. The incumbent will be technical expert in critical reagent qualification and will perform critical data review of critical reagent qualifications. In addition, the incumbent will lead/initiate investigations of assays that perform out of specification, especially when critical reagents may play a role.

ROLE RESPONSIBILITIES

Be a technical expert of several biofunctional and ligand binding assays and a recognized subject matter expert for reagent performance in cross-functional and program teams. Presents updates of reagent qualification and assay troubleshooting in HTCT, cross-functional and program team meetings. Develop and execute reagent qualification studies. Monitor reagent performance during clinical throughput, and initiates investigations. Participate in assays qualification and validations, establishing baseline reagent performance. Source reagents from vendors or in-house materials. Identifies additional vendors, as needed. Participates in evaluation of custom materials prepared under contract. Coordinate with other senior managers, project PI(s), heads of BFA and LBI teams and/or contract laboratories to plan/schedule reagent evaluations. Provide project related instructions as needed. Presents experimental results at group meetings, project meetings and department meetings. Manage a team of 3 5 direct reports and provide managerial guidance. Prepare and revise documents associated with reagent qualifications, including test methods, operating procedures, technical reports and regulatory documents, as needed. Attend corporate and departmental training, as available. Satisfactorily completes all cGLP, safety and other assigned training in conformance with job/departmental requirements.

QUALIFICATIONS

  • PhD in a scientific discipline such as immunology, microbiology, virology, biochemistry and/or bacteriology with at least 3 years of experience.
  • Strong verbal and written communication skills are required.
  • Use of scientific reasoning skills to troubleshoot or improve assay performance, data systems and clinical process.
  • Prior experience in high-throughput assays, such as opsonophagocytic assays, serum bactericidal assays, and multianalyte profiling platforms, such as the Luminex platform, is preferred but not required.
  • Training in a cGLP environment and other international regulatory guidelines is preferred but not required.
  • PHYSICAL/MENTAL REQUIREMENTS

    Ability to perform work while standing/sitting.

    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.

    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.

    Other Job Details:

  • Last Date to Apply for Job: 5/22/2019
  • Additional Location Information: Pearl River, NY
  • Eligible for Employee Referral Bonus
  • N (Other) (United States of America)

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


    Associated topics: antibody, bacteria, clinical, disease, immuno oncology, immunology, nephrology, pharmacy, physiologist, trauma

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