1+ months

Laboratory Analyst & Project Coordinator

Pfizer
New Haven, CT 06510
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**Job Summary**



As a Safety Laboratory Analyst, the individual is responsible for performing routine and special clinical laboratory testing using automated, semi-automated and/or manual methods and equipment, coordinating and organizing assigned laboratory sections (including Hematology, Chemistry, Urinalysis, Immunoassay, Coagulation and Biomarkers). Responsibilities will also include: quality control, validation of new assays, new employee training, documentation, own training, instrument owner duties, laboratory equipment use, calibration, maintenance, inventory and sample processing.



As a Laboratory Coordinator, the individual will assist in clinical trial study set-up activities and data cache (study QC and reconciliation of issues) at study closeout, as assigned by the Laboratory Coordinator Lead. Works with PCRU study team members or Biomarker Leads to execute clinical trials or external biomarker development that meet regulatory guidelines, project team timelines, and quality requirements.



May serve as a back-up for specimen processing and sample shipping as required.



May serve as a back-up for analysis of Biomarker specimens.



Serves as an expert to troubleshoot laboratory-based issues that arise in the preparation, conduct, close-out of clinical trials.



Provides novel approaches to resolving problems and issues that may arise within the Safety or Biomarker Laboratories during assay conduct.



**What You Will Achieve**



As a Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be part of a team that is addressing the critical task of rejuvenating our pipeline with innovative, differentiated First-In-Class/ Only-In-Class programs in the years to come. This will be addressed by generation of strong data packages from target hypotheses derived from academic outreach and initiatives. You will be an essential member of this team and creatively design and execute key experiments to address the basic and translational biology of novel drug targets, their molecular pathways, and their connection to human disease. You will support projects in one or more therapeutic areas of interest to Pfizer including Immunology, Oncology, Immuno-Oncology, Neurodegenerative Disease, etc.



With your deep knowledge in the discipline, you will be an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.



It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.



**Job Responsibilities**



+ Perform all routine and special clinical chemistry, hematological, coagulation, and urinalysis, immunological and other tests according to the Standard Operating Procedures. - Implement and validate new assays. May assist with assay development. Coordinates with the guidance of the Laboratory Manager new methods validation and instruments implementation. - Performs all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control and calibration data. - Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures. - Perform and document required routine maintenance and calibration of laboratory instruments. - Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs. - Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples. Collect biological samples from study subjects. Process samples for analysis and storage. Oversee the specimen storage inventory. Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report. - Train and or mentor personnel in laboratory procedures as assigned. - Perform data entry and monitor laboratory information system (LIS). - Maintain clean and safe work areas per SOP. - Write new or revise procedures for the SOP or Manuals as assigned. Instrument Owner: Performs monthly QC report and reviews with Laboratory Quality Coordinator. Maintains reagent and consumable inventory. Performs lot to lot QC comparison and sets QC ranges. Schedules preventative maintenance. Monitors that maintenance is performed. Reviews SOPs yearly for relevance and documents review. Assists the Laboratory Manager with the Laboratory Quality Coordinator and Improvement Plan by identifying pertinent quality goals, plans and procedures for measuring and monitoring quality, procedures for responding to insufficient quality and for improving quality by documentation and development. Implementation of Corrective Actions/ Preventive Actions /Immediate Actions if needed. Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits.



**Qualifications**



**Must Have**



Minimum of a Bachelor's Degree in Medical Technology.



Bachelor's degree in chemical, physical or biological science from an accredited college or university may be considered if educational requirements meet CLIA 88 standards for high complexity laboratories:



16 semester hours of biology courses, which are pertinent to medical sciences



16 semester hours of chemistry (at least 6 hours of Inorganic Chemistry)



3 semester hours of math



American Society of Clinical Pathology (ASCP) certified. Will consider individual without certification if they meet all other requirements.



Minimum of 7 years of relevant work experience in pharmaceutical, hospital, or medical research.



Knowledge of clinical trials a plus.



Working knowledge of GxP, GCP, CAP, and CLIA regulations.



Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.



Working knowledge of Word applications.

**Nice-to-Have**



+ Understanding and demonstrated proficiency in handling laboratory projects.

+ Knowledge of a pharmaceutical clinical research unit environment.

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

+ Ability to challenge existing paradigms in clinical research and to encourage novel designs/ideas and research approaches to improve study conduct, data capture, retrieval and submission processes.

+ Demonstrates team work by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



NA



**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
Posted: 2021-06-24 Expires: 2021-07-25
Sponsored by:
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Laboratory Analyst & Project Coordinator

Pfizer
New Haven, CT 06510

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