Sr. Scientist, Biomarker Assay

ROLE SUMMARY

The Biomarker Assay Senior Scientist will be based in New Haven, CT and will work closely with biomarker assay scientists to identify clinically significant biochemical markers and to develop/adapt biomarker assays for routine use in a clinical trial setting. A senior scientist is responsible for executing biomarker assays that support Pfizer clinical trials conducted at the Pfizer Clinical Research Unit (PCRU) as well as those conducted at external sites.

ROLE RESPONSIBILITIES

• Design and develop bioanalytical assay formats, select techniques, and optimize conditions
• Independently plan and execute assay performance evaluations and validation procedures that comply with current regulatory guidance and industry best practices
• Contribute to study design from the perspective of sample collection and processing through the following:
  • Critical review and contribution to clinical protocols
  • Interaction with study teams and/or the Clinical Assay Group (CAG) to identify and resolve issues before study start
  • Management of resources to efficiently support studies and on the scheduled timelines
• Work with finance, study teams, CAG, and data management to provide budget estimate, timelines, and metrics for biomarker assays as appropriate
• Conduct routine clinical testing using validated biomarker assays to support Pfizer clinical studies as needed
• Continue to acquire new skills in biomarker methods, instruments, and technologies
• Organize and maintain the Biomarker Laboratory to ensure cleanliness, safety, adequate inventory, and required quality documentation for instruments and materials
• Perform all quality control checks on instruments and biomarker assay performance before clinical testing
• Communicate regularly with Biomarker Laboratory Manager and/or Laboratory Director to provide project status updates and to help identify/resolve/improve any gaps in lab quality or compliance
• Analyze, summarize (with statistics), and document all experimental results; Perform electronic data entry using IDBS E-WorkBook and a Laboratory Information System
• Write and review lab SOPs, work instructions, test methods, method validation plans/reports, bioanalytical study plans/reports
• Train and guide biomarker assay scientists; QC review biomarker assay scientist work
• Assist the Clinical Safety Lab as needed

BASIC QUALIFICATIONS

• Degree in biological or biochemical science plus relevant working experience (years) in a pharmaceutical/biotechnology laboratory setting:
  • Bachelor's degree with 9+ years work experience
  • Master's degree 7+ years work experience
  • PhD with at least 2-3 years work experience
• Solid background and extensive experience in the development and validation of multi-parameter flow cytometry assays used for longitudinal studies
  • Independently sets up assay-specific application settings and compensation matrices on a flow cytometer
  • Independently monitors instrument and assay performance over time and readily troubleshoots downward trends
• Advanced knowledge of flow cytometry data analysis software (FlowJo or FCS Express preferred) and techniques for consistent analyses over time, between subjects, and between biomarker analysts
• Basic human immunology coursework
• Firm understanding of bioanalytical assay validation guidance issued by regulatory agencies for drug development
• Understanding of clinical trial research, GCP and GCLP regulations
• Ability to think critically to manage multiple projects, timelines, and to resolve laboratory issues in a timely manner
• Ability to write scientifically, being thorough yet concise, and compliance with good documentation practices
• Ability to apply basic statistics and to graph large data sets
• Demonstrated teamwork through the following:
  • Positive, friendly attitude
  • Problem solving when faced with a challenge
  • Adapting to change with a flexible work schedule and/or willingness to learn new skills
  • Communicating frequently and openly to build trust in working relationships
• Working knowledge of computers and Microsoft Office applications (Excel, Work, Powerpoint, Outlook, Teams)

PREFERRED QUALIFICATIONS

• Technical and functional knowledge of protein detection and quantification using common biochemical techniques [ELISA, MSD(ECL), Luminex, etc.]
• Work experience with electronic laboratory notebook applications, such as IDBS E-WorkBook and/or laboratory information systems
• Experience automating aspects of laboratory data acquisition, data entry, and data analysis
• Work experience in laboratory quality assurance practices
• Experiencewith regulatory lab audits and inspections

PHYSICAL/MENTAL REQUIREMENTS

Must be able to wear personal protective equipment at all times in the laboratory: long lab coat, safety glasses, disposable gloves, and, currently, a face mask (dust mask or N95 mask dependent on the lab activities assigned).

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 which are based on project needs.

Other Job Details

#LI-PFE

Eligible for Employee Referral Bonus

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

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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