East Hanover, New Jersey, United States
24 hours ago
CAR-T Analytical Development Scientist - Group Leader

Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!

Job Description

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.

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 membersSupervise PSS teamRecord and maintain meticulous records in electronic laboratory notebook in compliance with Quality standardsIdentify opportunities for method improvementExecute qualification/optimization of analytical methodsDrive project timelines and deliverables while meeting internal quality and data integrity requirementsCommunicate effectively and present complex data within the department and cross-functionallyAuthor and review method related technical documents to ensure completeness, accuracy, consistency and claritySupport 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 experienceLeadership skillsUnderstanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assaysExpertise with aseptic techniqueAbility to communicate clearly with internal or cross-functional teamsDetail-oriented with expertise in problem solving & demonstrated ability to work in a team environmentEstablished ability to work in a regulated environmentGood presentation skills and scientific/technical writing skillsUnderstanding of the concepts of cGxPStrong written and verbal communication skills are essential

PREFERRED QUALIFICATIONS:

Experience with mammalian cell culture, Human T-cell cultureExperience writing laboratory SOPs and technical instructions3-5 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidayYearly goal-based bonus & eligibility for merit-based increasesCompensation: $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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