CAR-T Analytical Development Scientist Group Leader

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 clients 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.

POSITION RESPONSIBILITIES:

• Perform analytical testing including flow cytometry cell count cell viability qPCR/dPCR ELISA potency etc. following appropriate SOPs and 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

Qualifications :

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

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 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: $85000-$102000 per year based on education and experience

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time