Lead Scientist, CAR-T Product Characterization

Johnson & Johnson Innovative Medicine; Malvern (Chester County); On-site; USD 130,000 - 190,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Scientist, Product Characterization – Advanced Therapies to advance in vivo CAR-T characterization strategies. The role is based in Malvern, PA, with opportunities in Spring House, PA or Leiden, Netherlands.

You will execute comprehensive analytical programs and collaborate with multi-disciplinary teams to support regulatory submissions. The ideal candidate has a PhD with 3+ years or a Master/Bachelor with extensive relevant experience, strong

Qualifications

• Ph.D. or equivalent degree with 3+ years in biopharmaceutical development OR a Bachelor’s/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 targeted LV modalities.
• Lead identification and justification of CQAs for CGT products using Quality by Design (QbD) principles.
• Coordinate advanced methodologies for comparability and deep characterization of cell and gene therapy.
• Develop and refine control strategies linking process parameters to CQAs.
• Apply DOE and statistical modeling to establish structure–function and process–product relationships.
• Prepare IND/IMPD/BLA/MAA sections and interact with regulatory agencies.
• Communicate results to cross-functional teams and health authorities as needed.
• Foster partnerships with Process Development, data sciences, QA, and discovery teams.
• Contribute to SOPs and best practices for product characterization.

Job description

Johnson & Johnson is seeking a Principal Scientist, Product Characterization – Advanced Therapies to advance in vivo CAR-T characterization strategies. The role is based in Malvern, PA, with opportunities in Spring House, PA or Leiden, Netherlands.

You will execute comprehensive analytical programs and collaborate with multi-disciplinary teams to support regulatory submissions. The ideal candidate has a PhD with 3+ years or a Master/Bachelor with extensive relevant experience, strong