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Eurofins PSS Insourcing Solutions

CAR-T Associate Scientist

Eurofins PSS Insourcing Solutions, Grantville, Pennsylvania, United States

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Overview

The position provides analytical testing support and implementation of novel analytical methodologies for CAR-T cell therapy products. The Scientists will work with a client team in Research and Development and will coordinate and execute molecular, potency and characterization assays, qualification studies, and method transfer activities within their area of expertise. This role interfaces with Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet established timelines while maintaining high quality and data integrity. Responsibilities

Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following appropriate SOPs and procedures. In addition, review and approve data by other team members Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards Identify opportunities for method improvement Execute qualification/optimization of analytical methods Drive project timelines and deliverables while meeting internal quality and data integrity requirements Communicate effectively and present complex data within the department and cross-functionally Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency Qualifications

BASIC MINIMUM QUALIFICATIONS:

BA/BS or MS in biology, chemistry, biochemistry, microbiology or other related science, plus 1+ year of prior experience in industry or academia. Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays Expertise with aseptic technique Ability to communicate clearly with internal or cross-functional teams Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment Established ability to work in a regulated environment Good presentation skills and scientific/technical writing skills Understanding of the concepts of cGxP Strong written and verbal communication skills are essential PREFERRED QUALIFICATIONS:

Experience with mammalian cell culture, Human T-cell culture Experience writing laboratory SOPs and technical instructions 1-3 years of experience in pharmaceutical, biologics industry Additional Information

Position is Full Time, Monday – Friday First Shift. Candidates currently living within a commutable distance of East Hanover, NJ are encouraged to apply. Excellent Full-time Benefits Include Comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holiday Yearly goal-based bonus & eligibility for merit-based increases Compensation: $26.00 - $31.00 per hour based on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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