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Scientist

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
Mar 23, 2023

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Discipline
Health Sciences, Drug Development
Position Type
Full Time
Job Type
Staff Scientist
Organization Type
Pharma
Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

Consistently performs routine and complex analytical chemistry activities with a degree of independence. Demonstrates technical expertise in one or more analytical areas.

Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, in process samples, finished product, sterility testing, environmental monitoring samples, process & cleaning validation samples, package samples and components as well as some specialized techniques.

Assays are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements. In addition, the individual writes, reviews and approves protocols, reports, and investigations associated with the laboratory and to support method validation activities.

This position is responsible for providing time sensitive in-process testing in support of Operations as needed and with OBE 5 drug products.

Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as required or needed.

Compiles validation data into comprehensive reports. Work on analytical methods in support of new product launches and existing marketed products. Applies creative ability and specialized scientific knowledge to solving marketed product analytical problems or evaluating changes. Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize, excipients, in-process materials, and finished products.

Participate in Laboratory investigations, create Change Control, revise test methods, write protocol and perform approvals.

The position is accountable for ensuring that analytical measurements are accurate and that methods are in compliance with FDA and/or other applicable regulatory agency guidelines, cGMP, and corporate requirements.

How You Will Achieve It

  • Conduct assays: In addition to high technical competence, the colleague understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development.
  • Analyze results: Analyzes and interprets project/study/investigation/review results independently. May utilize Laboratory Information Management Systems (LIMS). Develops problem solving skills. Makes tactical decisions independently based on the results.
  • Train & Mentor: Trains analysts in new and existing procedures, techniques and governmental regulations as directed by management. Takes initiative; seeks out additional assignments, etc.
  • Lab Support: Responsible for planning and execution of all tasks needed to achieve routine goals. Seeks advice on planning from management when there are priority conflicts. Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. May assist in coordinating the testing activities of the group.
  • SOPs and Admin: Able to make independent contributions to the development of new technologies developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.


Qualifications

  • A minimum of a BS/BA in Chemistry or Biochemistry or Advanced degree preferred.
  • This position requires 5 years' experience within Quality Control or other relevant analytical experience in the pharmaceutical industry. General lab equipment. Equipment troubleshooting.
  • Making sound and effective decisions under pressure.
  • Working with other manufacturing sites to understand a broader perspective.
  • Exposure to Regulatory inspections including direct interactions.
  • Ability to effectively work within Quality Control, and across network channels, to accomplish goals.
  • Knowledge of ICH and other applicable industry standards.
  • Understanding the principles of Data Integrity.


Physical/Mental Requirements

  • Ability to perform mathematical calculations.
  • Ability to perform complex data analysis.


Non-Standard Work Schedule, Travel, or Environment Requirements

  • Work Location Assignment:On Premise
  • Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as required or needed.


Other job details

  • Last day to apply: March 30, 2023.
  • Eligible for employee referral bonus: Yes.


Relocation assistance may be available based on business needs and/or eligibility.

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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