Principal Scientist, CAR-T Product Characterization

Johnson & Johnson Innovative Medicine; Spring House (PA); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, Product Characterization – Advanced Therapies to lead product characterization strategies for in vivo CAR-T and related modalities across Malvern, PA, Spring House, PA, or Leiden, NL.

The role focuses on defining CQAs, developing analytical methods, and coordinating regulatory submissions with cross-functional teams within a dynamic, matrix environment.

Qualifications

• Ph.D. or equivalent with 3+ years in biopharmaceutical development.
• 2+ years of analytical control strategy experience on ATMPs such as CAR T, lentiviral vectors and gene therapy products.
• Demonstrated expertise in CQA assessment and developing control strategies for advanced therapies.
• Experience with design, execution and optimization of analytical techniques for orthogonal characterization of cell therapy and gene therapy products.

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.
• Lead 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.
• Author or coordinate IND/IMPD/BLA/MAA sections & interact with regulatory agencies.

Skills

Analytical reasoning

Biochemistry

Molecular biology

CAR-T

DOE

Regulatory knowledge

Education

Ph.D. in Biochemistry/Immunology/Virology/Biological Science

Bachelor/Master with 6–8 years in related field

Tools

DOE

Job description

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, Product Characterization – Advanced Therapies to lead product characterization strategies for in vivo CAR-T and related modalities across Malvern, PA, Spring House, PA, or Leiden, NL.

The role focuses on defining CQAs, developing analytical methods, and coordinating regulatory submissions with cross-functional teams within a dynamic, matrix environment.