Johnson & Johnson Innovative Medicine · 8 hours ago
Principal Scientist, Product Characterization – Advanced Therapies
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expJohnson & Johnson Innovative Medicine is dedicated to advancing healthcare solutions through innovative therapies. The Principal Scientist will focus on developing product characterization strategies for advanced therapy modalities, ensuring compliance with health authority standards while collaborating with multi-functional teams.
Pharmaceuticals
Responsibilities
Define and implement product characterization strategy for cell and gene therapy (CGT) modalities from early development to late stages of development
Lead the identification and justification of CQAs for CGT products using the Quality by Design (QbD) principles
Lead the execution of the advanced methodologies associated with 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 appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address product characterization related inquiries
Effectively communicate characterization results and scientific data to cross-functional teams, project teams, and health authority as needed
Promote strong partnerships and collaboration with Process Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery
Contribute to technical forums both internal and external to the company to share knowledge and approaches related to deep product characterization strategies as they relate to cell and gene therapy products
Identify/collaborate with partners in academia or industry to implement innovative ideas or characterization approaches
Stay up to date with industry standards, guidelines, and regulatory requirements related to Advanced therapies, comparability studies and product characterization
Author comprehensive reports and presentations to communicate findings and technical data to internal and external stakeholders
Contribute to the development and enhancement of standard operating procedures (SOPs) and best practices for product characterization
Qualification
Required
Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development OR a Bachelor's or Master's degree with 6-8 years of relevant experience is required
2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products
Demonstrated expertise in CQA assessment and developing control strategies for advanced therapies
Experience with the design, execution and optimization of a broad range of analytical techniques for orthogonal characterization of cell therapy and gene therapy products
Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data
Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly
Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices
Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required
Ability to work collaboratively in a complex, matrix environment
Preferred
Understanding of the connections between clinical, process/product development, and biological outcomes
Experience with regulatory submissions and interactions with agencies such as the FDA or EMA
Previous experience in project management or leading cross-functional teams is a plus
Proficiency in statistical analysis and equivalency assessment is a plus
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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