12 days old

PCRU Biomarker Assay Scientist

Pfizer
New Haven, CT 06510
**ROLE SUMMARY**



The Biomarker Assay Scientist will be based in New Haven, CT but will support Pfizer clinical trials conducted at the Pfizer Clinical Research Units as well as those conducted at external sites. The job entails the detection and quantification of pharmacodynamic markers in human trial participants. The individual will serve as an expert and full team participant to troubleshoot and provide novel approaches to resolve laboratory-based issues that arise in preparation, conduct, and close-out of bioanalytical studies.



**ROLE RESPONSIBILITIES**



+ Handles, processes, tests, and manages human biospecimens in compliance with GCP and GCLP regulations.

+ Operates, maintains, and qualifies complex laboratory instruments.

+ Applies scientific knowledge and technical expertise to develop specialized biomarker assays, to troubleshoot/optimize routine biomarker assays, and to validate assay performance according to current regulatory requirements.

+ Writes, revises, and reviews laboratory SOPs/WIs, test methods, method validation plans/reports, and bioanalytical study plans/reports.

+ Works with project teams to test biospecimens according to the study plan, all Pfizer policies, and GxP regulations.

+ Meets timelines issued by the study teams for data file reporting and document filing.

+ Documents all laboratory activities in an electronic laboratory notebook application using good documenting procedure.

+ Independently performs data entry, analysis, and review using laboratory information system(s).

+ Manages own time and develops plans for short-term work activities/experiments on own projects.

+ Communicates regularly with the laboratory manager and study monitor to provide project status updates, propose best approach to complex issues, to notify of noncompliance issues, or to help resolve laboratory conflicts.

+ Provides guidance and trains project team members on laboratory tasks.



**BASIC QUALIFICATIONS**



+ Bachelor's degree in chemical or biological science plus 6 years or Master's degree in chemical or biological science plus 4 years of relevant work experience in a pharmaceutical/biotechnology laboratory setting.

+ Technical expertise in flow cytometry that includes assay design, instrument set-up, and data analysis (FlowJo or FCS Express preferred); Knowledge of other cell-based assay platforms.

+ Deep knowledge of protein detection and quantification techniques with technical expertise in ELISA, MSD, and/or Luminex platforms.

+ Experience handling biospecimens, working at BSL2/BSL2+.

+ Ability to apply basic statistics and to graph large data sets.

+ Knowledge of clinical trial research, GCP and GCLP regulations.

+ Knowledge of clinical biomarker assay validation requirements issued by regulatory agencies.

+ Ability to think critically to manage multiple projects, timelines, and to resolve laboratory issues in a timely manner.

+ Demonstrated teamwork by having a positive attitude and an ability to problem solve when faced with a challenge, by adapting to change with a flexible work schedule and a willingness to learn new skills, by communicating frequently and openly to build trust and relationships.

+ Working knowledge of computers, Microsoft Office applications (Excel, Work, Powerpoint, Outlook, Teams), laboratory data handling and data analysis systems.

+ Ability to write scientifically, being thorough yet concise.



**PREFERRED QUALIFICATIONS**



+ Demonstrated understanding of the complexities and recent developments in clinical biomarker research.

+ Work experience with electronic notebook applications, such as IDBS E-WorkBook.

+ Work experience with laboratory information systems, such as HNA Millenium Cerner.

+ Work experience managing large data sets, especially flow cytometry.

+ Experience automating aspects of laboratory data acquisition, data entry and data analysis.

+ Knowledge of CAP, CLIA safety laboratory regulations and clinical safety laboratory testing (Chemistry, Hematology, Coagulation, Immunoassay).



**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).

+ Must be able to perform repetitive lab tasks, such as opening/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 which are based on project needs.



**Other Job Details:**



+ **Last Date to Apply for Job:**

+ Eligible for Employee Referral Bonus: YES



**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



\#LI-PFE

Categories

Posted: 2021-02-17 Expires: 2021-03-19

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PCRU Biomarker Assay Scientist

Pfizer
New Haven, CT 06510

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