Principal Scientist, CAR-T Product Characterization

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 103,000 - 146,000; Full time

Job summary

Johnson & Johnson seeks a Principal Scientist, Product Characterization – Advanced Therapies to lead strategy for in vivo CAR-T products in Leiden/MA/Spring House. You will direct CQAs, apply QbD principles, and drive advanced analytical methods for cell and gene therapies.

The role requires deep expertise in biotherapeutics, analytical development, and regulatory interactions, with mentoring duties and strong collaboration across functions.

Qualifications

• Ph.D. or equivalent with 3+ years in biopharma development OR a Bachelor’s/Master’s with 6–8 years of relevant experience.
• Experience with ATMPs such as CAR-T, lentiviral vectors and gene therapy products.
• Design, execution and optimization of analytical characterization assays.

Responsibilities

• Define and implement product characterization strategy for in vivo CAR-T across modalities.
• Lead identification of CQAs for CGT products using QbD principles.
• Coordinate advanced methodologies for comparability and deep characterization.
• Communicate results to cross-functional teams and health authorities.

Skills

CQA assessment

Advanced therapy characterization

DOE & statistics

Multidisciplinary collaboration

Regulatory communication

Analytical development

Team mentoring

Education

Ph.D. in Biochemistry/Immunology/Virology or related

Bachelor's/Master with 6–8 years in biopharma

Job description

Johnson & Johnson seeks a Principal Scientist, Product Characterization – Advanced Therapies to lead strategy for in vivo CAR-T products in Leiden/MA/Spring House. You will direct CQAs, apply QbD principles, and drive advanced analytical methods for cell and gene therapies.

The role requires deep expertise in biotherapeutics, analytical development, and regulatory interactions, with mentoring duties and strong collaboration across functions.