Senior Scientist, Cell Therapy Development

Johnson & Johnson Innovative Medicine • Spring House, PA

5d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Biotherapeutics R&D Job Category: Scientific/Technology All Job Posting Locations: Spring House, Pennsylvania, United States of America Job Description: About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Scientist, Cell Therapy Development to be based in Spring House, PA. Purpose: The Senior Scientist, Cell Therapy Development, Cell and Gene Therapy Development, a department in the Therapeutic Development and Supply (TDS) organization, functions as a scientific subject matter expert, providing guidance on formulation and process development, scale-up, and technology transfer for cell therapy drug product manufacturing. They will also work and partner with colleagues in MSAT, quality, regulatory, and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

Requirements

• Minimum of a Master’s degree is required
• PhD in a technical field (e.g. Biochemistry, Chemical Engineering, Pharmaceutical Science, Biotechnology) is highly preferred
• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level