Principal Scientist, Product Characterization – Advanced Therapies

Role: Principal Scientist, Product Characterization – Advanced Therapies, focusing on developing comprehensive characterization strategies for cell and gene therapy modalities such as in vivo CAR-T, LNP, mRNA, and targeted lentiviral vectors. Responsibilities: define product characterization strategies from early to late development, establish and justify critical quality attributes (CQAs) using QbD principles, lead advanced assay development for comparability and deep characterization, develop control strategies linking process parameters to product quality, and author regulatory documentation. Engage with regulatory agencies, communicate findings to cross-functional teams, foster collaboration with internal departments and external partners, stay current with regulatory standards, and contribute to SOP development. Qualifications: Ph.D. or equivalent in Biochemistry, Immunology, Virology, or related fields with 3+ years (or 6-8 years with Bachelor’s/Master’s). Experience required in analytical control strategies for ATMPs, CQA assessment, and assay development for cell and gene therapies. Skills include detailed analytical techniques, scientific communication, mentorship, and cross-functional collaboration. High-value biopharma specifics: focus on advanced therapies (CAR-T, lentiviral vectors, gene therapy), development stage from early to late, with regulatory and quality oversight. Work setup: location flexible among Malvern, PA, Spring House, PA, or Leiden, Netherlands.