Johnson & Johnson · 4 hours ago
Principal Scientist, Cell Therapy Process Development
Spring House, Pennsylvania, United States of America
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expJohnson & Johnson is a leading healthcare company dedicated to innovative medicine. They are seeking a Principal Scientist to enhance CAR-T cell therapy products for cancer patients, focusing on process development and optimization within a cross-functional team environment.
Hospital & Health Care
Responsibilities
Leverage own experience in cell therapy process development to guide autologous platform and process development efforts focused on patient-derived CAR-T cells
Design, lead, and execute process characterization studies for autologous CAR‑T manufacturing, including development of study protocols, implementation of DOE/statistical analyses, preparation of comprehensive study reports and risk/impact assessments
Mentor and train junior team members on experimental procedures and foster their professional development
Collaborate with and participate in cross-functional teams to facilitate IND-enabling, clinical Phase I/II-enabling activities as well as BLA enabling workstreams
Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product
Utilize phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy
Support successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners
Communicate program progress and issues to management, stakeholders and to regulatory agencies as necessary
Qualification
Required
PhD in Immunology, Biological Sciences or Biomedical Engineering with at least 5 years of relevant industry experience (academic experience post-graduate also considered) OR a BS or MS in Biological Sciences, Biomedical Engineering or Immunology with 6-8 years of experience
Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required
Knowledge and experience in autologous CAR-T cell therapy required, together with a demonstrated understanding of T cell biology, and fundamental immunology. Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is required
Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required; expertise in gene editing using lentiviral vector, flow cytometry and potency assays is advantageous
Proven leadership skills and problem-solving experience in cell therapy industry with an emphasis on pipeline projects
Deep understanding of biologics industry process development strategies and best practices as applied from early development to late stage and commercialization
Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data. Must have excellent communication, interpersonal and collaborative skills
Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Highly adaptable and responsive, and committed to completing tasks in a timely fashion
Occasional weekend work may be required
This role may require up to 10% travel as needed
Preferred
Analytical Reasoning
Biochemistry
Biotechnology
Chemistry
Manufacturing, and Control (CMC)
Clinical Research and Regulations
Clinical Trial Designs
Coaching
Critical Thinking
Drug Discovery Development
Emerging Technologies
Molecular Diagnostics
Organizing
Pharmacovigilance
Presentation Design
Process Improvements
Productivity Planning
Scientific Research
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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