Eurofins PSS Insourcing Solutions
CAR-T Analytical Development Scientist - Group Leader
Eurofins PSS Insourcing Solutions, Grantville, Pennsylvania, United States
CAR-T Analytical Development Scientist - Group Leader
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 CAR-T cell therapy products. The team will coordinate and execute molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise. They will interface with functions such as Process Development, Quality Control and Manufacturing Sciences & Technology to drive projects to meet established timelines while maintaining high quality and data integrity standards.
Position Summary Lead and support a team performing analytical testing and development activities for CAR-T products, ensuring accurate data generation, method qualification/optimization, and timely delivery of project milestones.
Responsibilities
Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc., following SOPs; review and approve data.
Supervise PSS team and ensure meticulous record-keeping in electronic laboratory notebooks in compliance with quality standards.
Identify opportunities for method improvement and drive qualification/optimization of analytical methods.
Drive project timelines and deliverables while maintaining 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 for completeness, accuracy, consistency and clarity.
Support tracking and trending systems and programs for testing, evaluation and monitoring of quality and efficiency.
Qualifications BASIC MINIMUM QUALIFICATIONS
BS in biology, chemistry, biochemistry, microbiology or related science with 5+ years of industry experience or MS with 3+ years of industry experience.
Leadership skills and ability to communicate clearly with internal and cross-functional teams.
Understanding of principles underpinning analytical methods such as flow cytometry, PCR, ELISA, and cell-based assays.
Expertise with aseptic technique; ability to work in a regulated environment (cGxP).
Detail-oriented with strong problem-solving and scientific/technical writing skills.
PREFERRED QUALIFICATIONS
Experience with mammalian cell culture and 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.
Benefits
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: $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.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Referrals increase your chances of interviewing at Eurofins PSS Insourcing Solutions. Get notified about new Development Scientist jobs in East Hanover, PA.
#J-18808-Ljbffr
Position Summary Lead and support a team performing analytical testing and development activities for CAR-T products, ensuring accurate data generation, method qualification/optimization, and timely delivery of project milestones.
Responsibilities
Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, ELISA, potency, etc., following SOPs; review and approve data.
Supervise PSS team and ensure meticulous record-keeping in electronic laboratory notebooks in compliance with quality standards.
Identify opportunities for method improvement and drive qualification/optimization of analytical methods.
Drive project timelines and deliverables while maintaining 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 for completeness, accuracy, consistency and clarity.
Support tracking and trending systems and programs for testing, evaluation and monitoring of quality and efficiency.
Qualifications BASIC MINIMUM QUALIFICATIONS
BS in biology, chemistry, biochemistry, microbiology or related science with 5+ years of industry experience or MS with 3+ years of industry experience.
Leadership skills and ability to communicate clearly with internal and cross-functional teams.
Understanding of principles underpinning analytical methods such as flow cytometry, PCR, ELISA, and cell-based assays.
Expertise with aseptic technique; ability to work in a regulated environment (cGxP).
Detail-oriented with strong problem-solving and scientific/technical writing skills.
PREFERRED QUALIFICATIONS
Experience with mammalian cell culture and 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.
Benefits
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: $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.
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Referrals increase your chances of interviewing at Eurofins PSS Insourcing Solutions. Get notified about new Development Scientist jobs in East Hanover, PA.
#J-18808-Ljbffr