Job Information
J&J Family of Companies Manager, Cell Science MSAT CAR-T in Spring House, Pennsylvania
Manager, Cell Science MSAT CAR-T - 2406193345W
Description
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.
Qualifications
A master’s degree, preferably in medical biology, pharmacy, or a related discipline such as cell biology is highly preferred.
A minimum of 6-8 years of relevant experience in a pharma, hospital or academical environment is required.
Up-to-date knowledge of industry standards and regulatory requirements related to cellular therapies are critical.
Fully proficient in hematological sciences. In-depth knowledge and experience with leukapheresis and cell processing are required.
Working knowledge of the treatment of hematologic malignancies including acute leukemias, non-Hodgkin’s lymphoma and multiple myeloma is preferred.
Cell therapy development and regulatory submissions experience is highly preferred.
Experience in effective project management is required, as is a track record of change implementation.
Fully proficient in cGMP (US and EU) as well as GTP (US) and the Tissue and Cell Directives (EU) is required. Solid knowledge of the FACT/JACIE standards is essential too.
Ability to effectively work in multinational teams and enjoys a multicultural environment.
Experience in delivering independently and in a matrixed team environment is required.
Has demonstrated to be able to make decisions independently; an innovative and strategic thinker with broad vision is required.
Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required.
Travel may be required up to 20% of time.
The anticipated base pay range for this position is $99,000 to $170,200.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year.
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
Holiday pay, including Floating Holidays – up to 13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .
This job posting is anticipated to close on 06/29/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-New Jersey-Raritan
Other Locations NA-US-Pennsylvania-Spring House
Organization JANSSEN SUPPLY GROUP, LLC (6046)
Job Function Technology Operations Support
Req ID: 2406193345W