Johnson & Johnson Innovative Medicine · 8 hours ago
Senior Scientist, Cell Therapy Development
Johnson & Johnson is a leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases. The Senior Scientist in Cell Therapy Development will serve as a scientific subject matter expert, guiding the development and manufacturing processes for cell therapy drug products while ensuring compliance with regulatory standards.
Pharmaceuticals
Responsibilities
Establish and maintain, to industry standards and best-practices, internal capabilities for cell therapy drug product process development, scale-up, and technology transfer
Lead process development, scale-up, technology transfer, process validation, and health authority submissions for cell therapy drug products
Lead formulation, fill/finish, storage, diluent compatibility, drug product administration relevant studies relevant to the stage of development
Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions, and successfully resolve problems with supplies, methods, project issues, and deviations
Partner with MSAT, manufacturing site leads, quality, regulatory, and other functions for flawless introduction of manufacturing processes into production sites in accordance with pertinent regulatory guidelines
Design of experiments supporting rigorous control strategies and aligned with regulatory expectations
Scientific data interpretation and critical report review of global process development studies
Participate in issue-resolution teams through active engagement in scientific discussions and the shaping of strategies designed to support and inform critical development decisions
Qualification
Required
Minimum of a Master's degree is required
Minimum of 4-6 years' experience in developing and commercializing cell therapy drug product processes
Technical expert on current manufacturing processes and equipment and engineering scaling principles with the ability to apply knowledge to technology transfer and process optimization, aligned with HA-guidelines and GMP regulations
Proven skills in designing, conducting, and managing complex experiments, interpreting, and presenting complex data, and authoring protocols and reports to support development of cell therapy products or biologics
Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions
A proactive and flexible attitude, sense of urgency and excellent collaboration and inclusive team relationships skills
Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines
Preferred
PhD in a technical field (e.g. Biochemistry, Chemical Engineering, Pharmaceutical Science, Biotechnology) is highly preferred
Experience in designing and conducting biophysical and cell biological assays (isolation and culture of immune cells, transduction, flow cytometry, etc.)
Experience in cell therapy formulation, fill/finish, cryopreservation, and characterization
Familiarity with drug product development and pharmacy procedures for drug preparation and human administration
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
Funding
Current Stage
Late StageRecent News
2025-08-14
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