GLP Operations Lead (Senior Manager)

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Closing date
Jan 25, 2022

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

This position is in our Vaccine Research and Development - Analytical Development group. You will lead the expanding analytical GLP operation and ensure GLP readiness in support of release and stability of pre-clinical Toxicology vaccine materials. Your core responsibilities include maintaining a GLP-compliant analytical operation, providing technical leadership, strategy, and guidance to the analytical GLP group.

ROLE RESPONSIBILITIES
  • Acts as GLP technical expert providing leadership and direction to direct reports and other teams across Analytical and Formulation Development
  • Identifies existing GLP process improvements and develops innovative, advanced new concepts that improve the GLP-analytical work processes within Vaccines Research and Development - Analytical Development
  • Manages and leads people and GLP resources within Vaccine Research and Development - Analytical Development for multiple projects with a focus on method qualification and GLP 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).
  • Ensures compliant state of the Analytical GLP operation and leads investigations.
  • Provides input to senior management decisions that have impact on business direction and long-term strategy within Vaccine Research and Development - Analytical Development
  • Collaborate as necessary with appropriate leaders/scientists within Vaccines and across other departments
  • Authors, and critically reviews all GLP technical documentation.


QUALIFICATIONS
  • BS in Chemistry, Biochemistry or related discipline with a minimum of 7 years of related GXP operations experience, MS with a minimum of 6 years of related GXP operations experience or PhD with a minimum of 3 years of related GXP operations experience.
  • Extensive working knowledge of Good Laboratory Practice (GLP) and analytical method qualification based on ICH guidelines
  • Experience working in a vaccines and/or biopharmaceuticals environment
  • Experience supporting release and stability of materials characterized under GLP to be used in drug safety studies
  • Experience authoring and critically reviewing technical documents, including but not limited to SOPs, COCs and deviation investigations.
  • Experience leading/managing a team, including setting objectives and performance management
  • Experience leading direct reports, strategizing, and prioritizing group activities based on project priorities and timelines.
  • Strong verbal and written communication skills


PHYSICAL/MENTAL REQUIREMENTS

Standard conditions - sitting, standing

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

40 hours per week

OTHER JOB DETAILS

Eligible for Relocation Package

Eligible for Employee Referral Bonus

#LI-PFE

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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