Manager, Project Management
Pearl River, NY - USA
Job Summary
Why Patients Need You
At Pfizer our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple effective this role you will help drive the planning coordination and execution of external laboratory activities that support clinical assay programs enabling high-quality timely delivery for vaccine research and development.
What You Will Achieve
Clinical Immunology & Diagnostics (CID) develops and optimizes high-quality high-throughput immunoassays that are fit-for-purpose and oversees compliant assay execution to support Pfizers vaccine clinical research this role you will serve as a key member of the Vendor Reagent & Sample Logistics (VRSL) team coordinating clinical assay projects with external laboratories including academic institutions government laboratories and contract laboratories in both domestic and international settings.
You will support technology transfer for Pfizer-developed assays clinical sample testing assay performance monitoring issue investigation and vendor oversight. You will also work cross-functionally to help identify and qualify new collaboration and outsourcing opportunities maintain testing plans and timelines support budget tracking and contribute to the effective execution of multiple programs of moderate complexity.
Success in this position requires strong project coordination skills sound technical judgment and the ability to communicate laboratory results project status risks and next steps clearly across functions. You will apply scientific expertise operational discipline and collaborative problem-solving to support work within Pfizer and with external partners.
This position operates under managerial supervision with independence to manage day-to-day responsibilities and complete assigned tasks in accordance with relevant SOPs and applicable GCLP/GLP/GMP guidelines as required.
How You Will Achieve It
Serve as a point of contact for cross-functional teams supporting Pfizer clinical sample testing and Pfizer-associated assays at external laboratories for VRD programs.
Maintain testing schedules track milestones and provide budget-related support for outsourced activities.
Monitor assay performance at external laboratories and escalate risks issues and trends as appropriate.
Support assay investigations and issue resolution during routine and non-routine testing.
Support the development of responses to regulatory queries related to work performed at external laboratories.
Evaluate and help qualify external laboratories and/or in-house assays for outsourced Pfizer clinical sample testing.
Interpret and present experimental results and provide scientific support to external laboratory teams and internal stakeholders.
Monitor outsourcing trends and recommend process improvements efficiencies and synergies.
Support contracts and agreements with external laboratories including master service agreements quality agreements and scope of work documents.
Support audits and maintain productive collaborative relationships with external laboratories.
Execute responsibilities independently while escalating issues and seeking guidance as needed under managerial supervision.
Communicate experimental strategies and results effectively; contribute to SOPs and technical reports.
Satisfactorily complete all GCLP/GLP/GMP and safety training in conformance with VRD & HCID requirements.
Perform job responsibilities in compliance with GCLP/GLP/GMP and all other regulatory agency requirements.
Present experimental results project updates and key issues at group and project meetings.
Travel to external laboratories as needed may be required throughout the year.
Qualifications
Must-Have
Masters or Bachelors degree in microbiology immunology virology biochemistry or related discipline with minimum:
BA/BS:4 years
MBA/MS:2 years
Strong verbal and written communication skills with the ability to collaborate effectively across cross-functional teams and external partners.
Ability to design experiments and analyze and interpret scientific data.
Strong attention to detail organizational skills and commitment to operational excellence.
Ability to manage multiple priorities timelines and projects simultaneously.
Proficiency in Microsoft Office 365 applications standard project-tracking and AI tools.
Demonstrated ability to design and execute laboratory experiments and communicate results effectively both verbally and in writing.
Nice-to-Have
Strong working knowledge of microbiology immunology vaccine research and/or assay development.
Experience supporting clinical testing for clinical trials.
Hands-on experience working in a regulated (GCLP/GLP/GMP) environment and familiarity with international regulatory guidelines.
Familiarity with clinical trial execution vendor oversight and budget tracking.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform work while standing/sitting.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
This position may require evening work to meet critical business timelines.
Relocation support available
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.
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 providers 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. This position requires permanent work authorization in the United States.
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MedicalRequired Experience:
Manager
About Company
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