Principal Scientist, Product Characterization – Advanced Therapies

Role: Principal Scientist in Product Characterization for Advanced Therapies at Johnson & Johnson, focusing on cell and gene therapies including CAR-T, LNP, mRNA, and viral vectors. Objectives: develop and implement comprehensive characterization strategies aligned with regulatory standards; define CQAs using QbD principles; and support IND/IMPD/BLA/MAA submissions. Responsibilities: lead assay development, deep characterization, and comparability studies; establish control strategies linking process parameters to CQAs; apply DOE and statistical modeling; author technical documentation; collaborate with cross-functional teams and external partners; stay updated on industry and regulatory guidelines; and contribute to SOP development. Qualifications: Ph.D. or equivalent in Biochemistry, Immunology, Virology, or related field with 3+ years (or 6-8 years for Bachelor’s/Master’s), including at least 2+ years in analytical control strategy for ATMPs such as CAR-T and gene therapies. Skills: expertise in analytical techniques for cell/gene therapies, CQA assessment, technical communication, and team mentorship. High-value specifics: focus on advanced therapy modalities, regulatory engagement, deep product characterization, and development from early to late stages. Work setup: location options include PA and Netherlands, with a requirement for collaboration within a matrix environment.