Senior Scientist, Advanced Therapy Product Characterization

8852-Janssen Vaccines & Prevention B.V. Legal Entity; Netherlands; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Principal Scientist, Product Characterization – Advanced Therapies to lead characterization strategies for in vivo CAR-T, LNP, mRNA, and LV modalities. The role requires defining CQAs, developing control strategies, and collaborating across global teams.

This position emphasizes cross-functional leadership, regulatory engagement, and advanced analytics to support CGT product development and health authority interactions.

Qualifications

• PhD or equivalent advanced degree in Biochemistry, Immunology, Virology or related field with 3+ years of proven ATMP development experience.
• Alternatively, a Bachelor’s or Master’s with 6–8 years of relevant experience.

Responsibilities

• Define and implement product characterization strategy for in vivo CAR-T including LNP, mRNA and LV modalities.
• Lead identification and justification of CQAs for CGT products using QbD principles.
• Coordinate IND/IMPD/BLA/MAA sections and interact with regulatory agencies.

Skills

Analytical methods

CQA assessment

DOE/statistical modeling

Regulatory communication

Mentor and guide

Education

PhD or equivalent with 3+ years

Bachelor/Master with 6–8 years

Tools

Analytical techniques for orthogonal characterization

Job description

Johnson & Johnson is seeking a Principal Scientist, Product Characterization – Advanced Therapies to lead characterization strategies for in vivo CAR-T, LNP, mRNA, and LV modalities. The role requires defining CQAs, developing control strategies, and collaborating across global teams.

This position emphasizes cross-functional leadership, regulatory engagement, and advanced analytics to support CGT product development and health authority interactions.