Pfizer

Principal Scientist, GLP

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
November 16 2020
Ref
4795966
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

This position is within Vaccine Research and Development - Analytical Development group. The candidate is expected to manage analytical GLP operation and ensure GLP assay readiness in support of pre-clinical Toxicology studies. The core responsibilities include maintaining a GLP-compliant analytical laboratory, providing technical leadership, strategy, guidance, and day-to-day supervision to a group of scientists responsible for analytical method qualification/verification, release and stability testing. Work is expected to be done in a compliant manner according to SOPs and GLP guidelines when applicable.

How You Will Achieve It

  • Manage an Analytical GLP group within Vaccine Research and Development - Analytical Development with a focus on method qualification and routine sample testing using analytical and bioanalytical assays (HPLC, UV, ELISA, nephelometry, etc.) to support characterization and stability of various vaccine candidates (including nucleic acids, proteins, conjugates, and adjuvants).
  • Manage and oversee day-to-day operation of the Analytical GLP laboratory and ensure its compliant state.
  • Develop strategy for GLP analytical support of multiple concurrent projects.
  • Plan and coordinate reporting staff to ensure the timely execution of sample analysis and method qualification/ transfer activities to support the release, stability and routine testing of vaccine candidates for pre-clinical Toxicological studies.
  • Author, review, and track all GLP technical documentation to support assay qualification/verification, transfer, sample release and stability studies, as well as any deviations that may occur.
  • Supervise assigned staff including setting objectives, performance management, and work assignments. Manage and assist reporting scientists in the prioritization of their work to ensure timelines are met.
  • Closely work with management to define long term strategies for the group. Contribute and participate in general laboratory maintenance activities (such as maintenance of equipment, managing laboratory waste).


Qualifications

Must-Have

  • PhD in Chemistry, Biochemistry, or a related discipline with at least 6 years of academic, pharmaceutical, or biotechnology experience or an MS plus 8 years of related work experience is required.
  • Extensive working knowledge of Good laboratory Practice (GLP) and analytical method qualification based on ICH guidelines are a must.
  • Strong analytical skills, leadership skills are required for this position.
  • Ability to write technical documents, including but not limited to method SOPs, qualification reports, method transfer protocols and method transfer report, stability protocols and stability reports.
  • Ability to prioritize assay qualification and transfer activities, release and stability testing based on project priorities and timelines.
  • Strong leadership skills are required.
  • Strong verbal and written communication skills are required.


Nice-to-Have

  • Experience working with vaccines and/or biopharmaceuticals is desired.
  • Standard conditions - sitting, standing


Other Job Details:
  • Last Date to Apply for Job: November 20, 2020
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES


#LI-PFE

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

Similar jobs

Similar jobs