Manager, Cell Science Msat Car-T

Johnson & Johnson is currently seeking a Manager, Cell Science MSAT CAR-T to join our Manufacturing Sciences and Technology (MSAT) Organization located in Spring House, PA or Raritan, NJ.

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/.

Cancer immunology has rapidly progressed to one of the most promising forms of new treatments in which not the cancer, but the immune system is treated. This innovative form of autologous cellular therapy provides real hope to patients in need. The CAR-T organization within Johnson & Johnson is working on a full pipeline with our most advanced product for the treatment of multiple myeloma currently being scaled-up for broad patient access across the globe.

The Life Cycle Management team within Manufacturing Sciences and Technology (MSAT) works passionately on innovative technologies to improve our cell processes and enable broad patient access to life-saving CAR-T therapies. We are a fast-developing group and forward looking, working on aligning local regulatory requirements, technical improvements, being patient focused and support scientific innovation. This team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and international environment. This key role acts to strategize the smooth connection of our patients' cells with the personalized manufacturing process with one goal: to provide the best possible cells to manufacturing consistently and on a global scale.

As the cellular starting materials Subject Matter Expert who leads technical relationship with internal and external stakeholders, the applicant should be able to effectively educate and influence the external and internal environment around processes, fit for purpose requirements, procedures and scientific aspects of cell therapies. The successful candidate is able to appropriately balance regional requirements and standards with commercial needs at apheresis and cell processing sites as it relates to multiple programs: development, clinical trials, and commercial activities.

Given the central role in the organization, colleagues that are able to naturally nurture strong partnerships with other groups such as technical, scientific and commercial teams are most effective in achieving their goals.

Responsibilities:

• Can translate a global strategy into regional tactics, fostering innovation and aligning people with business goals and regulatory requirements.

• Can connect people, processes and infrastructure supporting sustained performance and growth.

• Conducts health agency and cell therapy industry research and market analysis and has demonstrated to be influential in shaping company and industry expectations related to apheresis and cell processing requirements for CAR-T therapies.

• Gives multisite and cross-functional technical and scientific support.

• Identifies robustness improvements and COGs reduction consistent with scale.

• Can act as technical SME for apheresis centers, local cryopreservation cell laboratories, as well as, contracted third party apheresis/cryopreservation centers.

• Has a proven track record as a strong and successful project manager.

• Define, then harmonize and standardize global requirements for leukapheresis collection. Align with in-country partners to ensure compliance with local regulations.

• Identifies opportunities in the regional cell therapy legal landscape and represents Johnson & Johnson on technical aspects in communication with law makers

• Connects with industry peers to enable harmonization and improvements impacting the starting material landscape.

• Is able to steer complex multi-dimensional programs and projects, can implement new technologies in a commercial supply chain

• Assert leadership in patient apheresis collection through active attendance at conferences and writing peer-reviewed publications.

• Oversees change and issue management related to apheresis and cryopreservation processes and equipment that could impact the product.