Senior Scientist, Sample Manager

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.

Role Summary

The Clinical Genetics & Biospecimens (CGB) team in Pfizer's Early Clinical Development Precision Medicine Group is seeking a highly motivated Senior Scientist Sample Manager to support the operations of our outsourced BioBank. The successful candidate will enable the shipment, tracking, documentation, and management of biospecimens throughout their lifecycle with vendors and the partner long-term storage facility, from intake to distribution and destruction.

Role Responsibilities

• Account for all biospecimens at the biobank from shipment from Central Labs/ clinical sites through to registration, storage, and destruction
• Develop, maintain and evolve infrastructure (i.e., template study documents, manifest templates and collection guidelines) for banked biospecimen collection in clinical trials
• Resolve discrepancies or gaps in documentation (e.g., rosters) and databases related to biospecimen sets; manage escalated queries and work with appropriate parties to resolve in a timely manner
• Execute the technical and operational procedures for the collection, storage, shipment, distribution and destruction of biospecimens from Pfizer clinical trials
• Address queries and advise on sample inventories and clinical trial documentation as key sample management point of contact to research and clinical teams
• Monitor biospecimen collections at biorepository and Central Labs and facilitate disposition of samples in collaboration with clinical team members
• Contribute to quality even investigations, and support implementation of corrective actions as needed to ensure compliance with sample management specifications and quality
• Propose innovative process improvements and best practices related to biospecimen management and assist in the implementation
• Represent sample management on cross-functional or vendor teams as subject-matter expert

Qualifications

Must-Have

• Bachelor's degree, preferably in the biological sciences, with a minimum of 6years of experience in appropriate scientific area related to the position
• Solid knowledge of human biofluid types, and collection and storage conditions thereof, and familiarity with considerations for conditions that may impact sample quality
  
• Experience working in a biological sample bank strongly preferred, understanding of the end-to-end sample management lifecycle
  
• Ability to organize, prioritize, and manage workflows; high level of initiative and ability to work independently
  
• Advanced interpersonal skills to navigate a diverse organization and ability to build collaborative working relationships with supervisors, peers, suppliers, customers, partners and stakeholders
  
• Technical leadership including ability to apply project management methodologies to achieving reliable and quality documentation of sample movements
  
• Excellent oral and written communication skills
  
• Strong ability to write work guidance and training documents, and experience authoring SOPs
  
• Knowledge of LIMS/database query tools with Microsoft Excel
  
• #LI-PFE
  

Nice-to-Have

• Master's degree or PhD and 2+ years of relevant experience
• Strong knowledge of the clinical trial process and GCP
  
• 3+ years of experience in the pharmaceutical industry; experience related to operational processes or systems in clinical trials
  
• Previous experience with sample management software
  

Sunshine Act

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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