Eurofins PSS Insourcing Solutions
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Overview
We have an exciting opportunity to support our client in analytical testing and implementation of novel analytical methodologies for our CAR-T cell therapy products. Scientists will work with a talented client team in Research and Development and coordinate execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface with Process Development, Quality Control and Manufacturing Sciences & Technology to drive projects to meet timelines while maintaining quality and data integrity. Position Responsibilities
Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following SOPs and procedures. 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 to assist in testing, evaluation and monitoring of quality and efficiency. Qualifications
BASIC MINIMUM QUALIFICATIONS: BS in biology, chemistry, biochemistry, microbiology or related science with 5+ years industry experience or MS with 3+ years industry experience. Understanding of basic scientific principles underpinning 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 problem-solving skills and 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 cGxP concepts. Strong written and verbal communication skills. PREFERRED QUALIFICATIONS: Experience with mammalian cell culture, human T-cell culture. Experience writing laboratory SOPs and technical instructions. 3-5 years of experience in pharmaceutical or 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 holidays Yearly goal-based bonus and eligibility for merit-based increases Compensation: $60,000-$72,000 per year based on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing Get notified about new Scientist jobs in East Hanover, NJ.
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We have an exciting opportunity to support our client in analytical testing and implementation of novel analytical methodologies for our CAR-T cell therapy products. Scientists will work with a talented client team in Research and Development and coordinate execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface with Process Development, Quality Control and Manufacturing Sciences & Technology to drive projects to meet timelines while maintaining quality and data integrity. Position Responsibilities
Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc. following SOPs and procedures. 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 to assist in testing, evaluation and monitoring of quality and efficiency. Qualifications
BASIC MINIMUM QUALIFICATIONS: BS in biology, chemistry, biochemistry, microbiology or related science with 5+ years industry experience or MS with 3+ years industry experience. Understanding of basic scientific principles underpinning 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 problem-solving skills and 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 cGxP concepts. Strong written and verbal communication skills. PREFERRED QUALIFICATIONS: Experience with mammalian cell culture, human T-cell culture. Experience writing laboratory SOPs and technical instructions. 3-5 years of experience in pharmaceutical or 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 holidays Yearly goal-based bonus and eligibility for merit-based increases Compensation: $60,000-$72,000 per year based on education and experience Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing Get notified about new Scientist jobs in East Hanover, NJ.
#J-18808-Ljbffr