ZipRecruiter
CAR-T Analytical Development Scientist - Group Leader
ZipRecruiter, East Hanover, New Jersey, us, 07936
Position Summary
We have an exciting opportunity for a Senior Scientist Group Leader to support and lead a team supporting our client in analytical testing and implementation of novel analytical methodologies for our client's CAR-T cell therapy products. This team will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards.
Note:
This description preserves the original language and content while conforming to formatting guidelines.
Position 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
Supervise PSS team
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
Basic Minimum Qualifications
BS in biology, chemistry, biochemistry, microbiology or other related science with 5+ years industry experience or MS and 3+ years of industry experience
Leadership skills
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
Qualifications
Experience with mammalian cell culture, Human T-cell culture
Experience writing laboratory SOPs and technical instructions
3-5 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 insurance
401(k) with company match
Paid vacation and holiday
Yearly goal-based bonus & eligibility for merit-based increases
Compensation: $85,000-$102,000 per year based on education and experience
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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We have an exciting opportunity for a Senior Scientist Group Leader to support and lead a team supporting our client in analytical testing and implementation of novel analytical methodologies for our client's CAR-T cell therapy products. This team will work with a talented and experienced client team in Research and Development and will be important points of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. This team will interface regularly and build relationships with other functions at the client site such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards.
Note:
This description preserves the original language and content while conforming to formatting guidelines.
Position 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
Supervise PSS team
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
Basic Minimum Qualifications
BS in biology, chemistry, biochemistry, microbiology or other related science with 5+ years industry experience or MS and 3+ years of industry experience
Leadership skills
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
Qualifications
Experience with mammalian cell culture, Human T-cell culture
Experience writing laboratory SOPs and technical instructions
3-5 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 insurance
401(k) with company match
Paid vacation and holiday
Yearly goal-based bonus & eligibility for merit-based increases
Compensation: $85,000-$102,000 per year based on education and experience
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr