Principal Scientist, CAR-T Product Characterization

Johnson Johnson

Leiden

On-site

EUR 69,000 - 120,000

Full time

4 days ago
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Benefits offered by this job

Annual bonus
Vacation days
Parental leave
Well-being reimbursement
Insurance plans

Job summary

Johnson & Johnson seeks a Principal Scientist in Biotherapeutics Development to lead product characterization for advanced therapies. The role focuses on in vivo CAR-T, LNP, mRNA, and LV modalities, coordinating CQAs and DOE-driven analyses within a matrix team across Leiden and global sites.

You will mentor scientists, collaborate with Process Development, QA, and data science teams, and contribute to regulatory submissions while staying current with industry standards.

Qualifications

  • Strong written and verbal communication skills.
  • Experience with analytical control strategies for ATMPs (CAR-T, LV vectors).
  • Ability to work in a matrix environment and mentor others.

Responsibilities

  • Define and implement product characterization strategy for in vivo CAR-T.
  • Lead identification and justification of CQAs for CGT products.
  • Lead execution of advanced methodologies for comparability and deep characterization.
  • Develop and refine control strategy linking parameters to CQAs.
  • Apply DOE and statistical modeling to establish structure–function relationships.
  • Coordinate IND/IMPD/BLA/MAA sections and interact with regulators as needed.
  • Communicate results to cross-functional teams and health authorities.

Skills

Analytical thinking
Communication skills
Mentor/guide juniors
Team collaboration

Education

Ph.D. or equivalent in Biochemistry/Immunology/Virology/Biological Science
Bachelor's or Master's with 6-8 years relevant experience

Job description

Johnson & Johnson seeks a Principal Scientist in Biotherapeutics Development to lead product characterization for advanced therapies. The role focuses on in vivo CAR-T, LNP, mRNA, and LV modalities, coordinating CQAs and DOE-driven analyses within a matrix team across Leiden and global sites.

You will mentor scientists, collaborate with Process Development, QA, and data science teams, and contribute to regulatory submissions while staying current with industry standards.

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