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Principal Scientist, Product Characterization – Advanced Therapies
Johnson & JohnsonPrincipal Scientist characterizing in vivo CAR-T, LNP, mRNA, and lentiviral products for Johnson & Johnson’s advanced therapies. Leading CQA, comparability, control strategy, and regulatory characterization work.
Core Competencies
Role fitCore Competencies
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Demonstrates expertise in product characterization strategies for in vivo CAR-T and advanced therapy medicinal products, with a strong focus on critical quality attributes and regulatory compliance. Proficient in analytical techniques, statistical modeling, and cross-functional collaboration to drive successful biopharmaceutical development.
Highest-signal resume keywords
Ph.D. In Biochemistry, Immunology, Virology, Or Biological ScienceAnalytical Control Strategy ExperienceCritical Quality Attribute AssessmentDesign Of Experiments And Statistical ModelingRegulatory Interaction And Documentation
ATS Keywords
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Hard Skills
Product Characterization StrategyQuality By Design PrinciplesComparability StudiesAnalytical Techniques OptimizationControl Strategies DevelopmentCell And Gene Therapy ProductsStatistical ModelingIND/IMPD/BLA/MAA AuthoringExperimental DesignData Interpretation
Soft Skills
Detail-OrientedHighly OrganizedStrong Written And Verbal CommunicationExcellent Interpersonal SkillsCollaborative Teamwork
Industry Keywords
Advanced Therapy Medicinal ProductsCAR TLentiviral VectorsGene TherapyRegulatory RequirementsQuality AssuranceTechnical ForumsBest PracticesProcess ParametersHealth Authorities
About the role
Key responsibilities & impact- Define and implement product characterization strategy for in vivo CAR-T, including LNP, mRNA, and targeted LV modalities from early through late development stages
- Lead identification and justification of critical quality attributes (CQAs) for cell and gene therapy products using Quality by Design principles
- Lead advanced methodologies for comparability and deep characterization of cell and gene therapy products
- Develop and refine control strategies linking process parameters to CQAs
- Apply design of experiments and statistical modeling to establish structure-function and process-product relationships
- Author or coordinate IND/IMPD/BLA/MAA sections and interact with regulatory agencies on product characterization inquiries
- Communicate characterization results and scientific data to cross-functional and project teams and health authorities
- Partner with Process Development, data sciences, Janssen Supply Chain, Quality Assurance, and Discovery leaders
- Contribute to internal and external technical forums on deep product characterization strategies
- Identify and collaborate with academic or industry partners on innovative characterization approaches
- Monitor industry standards, guidelines, and regulatory requirements for advanced therapies, comparability studies, and product characterization
- Author comprehensive reports and presentations communicating findings and technical data
- Contribute to standard operating procedures and best practices for product characterization
- Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices
Requirements
What you’ll need- Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or related field with 3+ years of proven biopharmaceutical development experience, OR a Bachelor’s or Master’s degree with 6–8 years of relevant experience
- 2+ years of analytical control strategy experience on advanced therapy medicinal products such as CAR T, lentiviral vectors, and gene therapy products
- Expertise in critical quality attribute assessment and control strategies for advanced therapies
- Experience designing, executing, and optimizing analytical techniques for orthogonal characterization of cell and gene therapy products
- Detail-oriented, highly organized, able to manage multiple tasks and tight timelines while delivering quality data
- Strong written and verbal communication skills for clearly conveying complex scientific concepts
- Excellent interpersonal skills and ability to operate effectively in a dynamic work environment
- Ability to work collaboratively in a complex, matrix environment
Benefits
Comp & perks- Inclusive work environment
- Accommodation support during the interview process for applicants with disabilities