Senior Scientist – Clinical Assay Development
Pearl River, NY 
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Posted 18 days ago
Job Description

ROLE SUMMARY

The candidate will perform and supervise lab-based development and validation of molecular biology assays for testing clinical samples in a regulated environment.

Incumbent will also handle multiple aspects of day-to-day laboratory management including task assignment for junior lab staff members, project coordination and data presentation. Must be experienced in PCR, molecular biology techniques for DNA and RNA extraction, and lab automation.Data analysis, project management, and supervisory experience are required.

ROLE RESPONSIBILITIES

  • Develop and validate PCR assays for detection and characterization of bacteria and viruses, or vaccine products, in clinical samples
  • Supervise laboratory staff
  • Organize and schedule multiple projects
  • Frequently present results and status updates to management
  • Effectively telework when required
  • Operate Hamilton Vantage workstation for execution of high-throughput sample analysis
  • Maintain lab records compliant with cGMP
  • Ensure lab equipment is functional and compliant
  • Oversee lab inventory including purchasing and reconciliation
  • Participate in cross-functional workflows
  • Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product biological characterization
  • Support method transfers to other groups and external partners
  • Analyze results and methods, solve analytical problems,troubleshoot assays and meet regulatory expectations for analytics
  • Contribute to preparation and review of standard operating procedures, method development reports, and qualification/validation protocols and reports
  • Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology staff members

BASIC QUALIFICATIONS

  • MS in biological science or biochemistry or molecular biology.
  • Minimum of 6 years of experience in molecular biology laboratory and PCR
  • Supervisory experience
  • Ability to work independently and prioritize work assignments
  • Ability to work in a matrixed environment with shared resources and effectively communicate across teams

PREFERRED QUALIFICATIONS

  • Strong experience working in a highly regulated laboratory environment
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs)
  • Ability to critically analyze data using statistical tools and to compile and review technical reports
  • Excellent record keeping abilities to adequately document analytical data generated in support of regulatory requirements
  • Strong communication, presentation, and writing skills

Other Job Details:

  • Eligible for Employee Referral Bonus

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

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Master's Degree
Required Experience
6+ years
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