PCRU Biomarker Assay Scientist
Job Description
Why Patients Need You
The Biomarker Assay Scientist will be based in New Haven, CT and will work closely with biomarker senior scientists/project leads to develop and validate biomarker assays for use in a clinical setting.
What You Will Achieve
They will execute clinical sample testing and are accountable for their own time management, data quality, and compliance with good clinical laboratory practices (GCLP).
How You Will Achieve It
Comply with GCLP, including all laboratory standard operating procedures (SOPs), work instructions (WIs), and test methods (TMs)
Complete all assigned training by the due date.
Comply with all EH&S guidances on lab safety in a BSL2+ facility.
Assist scientists in the writing and review of new or revised lab SOPs, WIs, TMs, or study documents.
Record all clinical biospecimen use, to include receipt, testing, disposal, or shipment offsite.
Record all lab procedures and results in an electronic notebook according to good documentation practices.
Review quality and accuracy of all work within an electronic notebook according to SOPs and WIs.
Record all deviations from lab SOPs, WIs, and TMs in an electronic notebook in real-time.
Qualify and maintain lab instruments according to SOPs and WIs.
Create and maintain an accurate inventory of unexpired lab reagents and consumables.
Maintain a clean and organized lab space.
Support green lab initiatives.
Conduct all biomarker assay validations and clinical testing according to study plans.
Continue to acquire skills in new lab methods, lab instruments, and lab technologies.
Make and qualify assay-specific quality control samples.
Assist scientists in the design and development of new biomarker assays and troubleshooting efforts.
Validate new templates used in data analysis or reporting.
Independently plan and execute daily experiments/work to achieve project goals and timelines.
Independently analyze and summarize data sets.
Collect human peripheral blood mononuclear cells according to a lab manual or TM.
Review data and content within method validation or bioanalytical study reports for accuracy.
Communicate frequently and openly.
Meet with biomarker project leads to ask questions, raise concerns, and provide status updates
Attend all weekly or biweekly biomarker study management meetings
Attend 1:1 meetings with Sr Lab Manager to ask questions, raise concerns, set performance and behavior goals, and plan growth development opportunities
Supervise, provide guidance to other lab personnel in areas of technical expertise
Observe and bring forward ideas for continuous improvement in lab areas where you work
May provide assistance to clinical safety laboratory
Display positive attitude, team spirit, and ability to adapt to change with a willingness to learn new skills and sometimes flexible work schedule
Qualifications
Degree in biological or biochemical sciences plus relevant work experience in a lab setting:
Bachelor’s degree with 5-8 years work experience or Master’s degree with 2-5 years work experience.
Extensive experience with:
Handling biospecimens, human or animal
Common data analysis applications (e.g. Microsoft Excel, XLFit or GraphPad Prism), descriptive statistics, and regression analysis
Common immunoassay techniques (e.g. ELISA, ECL) and data acquisition software (e.g. Molecular Devices SoftMax Pro or Meso Scale Discovery Methodical Mind), OR
Common flow cytometry techniques (e.g. multi-parameter surface or intracellular stains) and data acquisition software (e.g. Becton Dickinson FACSDiva)
Ability to work under limited supervision:
Applies technical skills/experience to new projects
Good time management and organizational skills
Strong written communication skills with experience using a laboratory notebook, paper or electronic
Strong verbal communication skills that promote transparency and trust
Familiar with Microsoft Office applications: Outlook, Teams, Word, and PowerPoint
Basic understanding of:
Metrics used to validate assay performance (e.g. precision, accuracy, linearity); bioanalytical assay validation guidance issued by regulatory agencies preferred
GxP regulations and/or with lab quality assurance practices
ORGANIZATIONAL RELATIONSHIPS
Daily: Biomarker senior scientists and principal scientists
Weekly: Lab Manager, Lab Systems/EWB Administrator
As needed: PCRU Training Coordinator, PCRU Quality Manager, PCRU Documentation Specialist, PCRU Data Manager, PCRU Clinical Specimen Processors, (external) Pfizer Clinical Assay Lead
PHYSICAL/MENTAL REQUIREMENTS
Must be able to wear personal protective equipment at all times in the laboratory: long lab coat, safety glasses, and disposable gloves. Must be able to perform repetitive tasks, such as opening and closing specimen tubes and pipetting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The nature of clinical lab testing requires a flexible work schedule that includes some evening and weekend hours based on project-specific needs.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
