Principal Scientist, Cell & Gene Therapy Characterization

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Career growth programs

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks a Principal Scientist for BioTD-AD to lead product characterization for in vivo CAR-T and gene therapy. You will shape characterization strategies, identify CQAs, and guide regulatory communications within a cross-functional team.

The role requires advanced experience in analytical development for ATMPs, strong data interpretation, and mentoring capabilities in a dynamic, matrix environment.

Qualifications

• Ph.D. or equivalent degree with 3+ years of proven experience in biopharmaceutical development.
• 2+ years of analytical control strategy experience on ATMPs such as CAR-T, lentiviral vectors and gene therapy products.
• Strong written and verbal communication skills; ability to mentor junior scientists and technicians.

Responsibilities

• Define and implement product characterization strategy for in vivo CAR-T including LNP, mRNA and targeted LV modalities from early development to late stages of development.
• Lead the identification and justification of CQAs for CGT products using Quality by Design (QbD) principles.
• Lead the execution of advanced methodologies for comparability and deep characterization of cell and gene therapy.
• Develop and refine the control strategy linking process parameters to CQAs.
• Apply DOE and statistical modeling to establish structure-function and process-product relationships.
• Coordinate IND/IMPD/BLA/MAA sections and interact with regulatory agencies.
• Communicate characterization results to cross-functional teams and health authorities as needed.
• Promote partnerships with Process Development, data sciences, Janssen Supply Chain, Quality Assurance, and Discovery.
• Contribute to technical forums and collaborations for deep product characterization strategies.

Skills

Analytical Reasoning

Biochemistry

Biotechnology

Chemistry

CMC Knowledge

Education

Ph.D. in Biochemistry or related field

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks a Principal Scientist for BioTD-AD to lead product characterization for in vivo CAR-T and gene therapy. You will shape characterization strategies, identify CQAs, and guide regulatory communications within a cross-functional team.

The role requires advanced experience in analytical development for ATMPs, strong data interpretation, and mentoring capabilities in a dynamic, matrix environment.