This job posting is anticipated to close on Mar 19 2025. We may however extend this time period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.
Summary
Individual contributor who is a developing subject matter expert in a scientific/technology field. Develops actionable insights for methods and research for the internal Technical Product Management community. Applies in-depth skills of the field to design and develop industry leading products. Contributes to technology projects, programs, and processes.
Description
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:
Technology Product & Platform ManagementJob Sub Function:
Technical Product ManagementJob Category:
Scientific/TechnologyAll Job Posting Locations:
Raritan, New Jersey, United States of America, US121 NJ Raritan - 1000 Highway 202 SJob 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 Technology Solutions Lead, CAR-T to be in Raritan, NJ
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.
Are you interested in joining a team that is passionate about improving the lives of cancer patients?
This new position is part of the MAKE Operational Technology Team and will work closely with the Site Lead of Supply Chain Systems. The Technology Solutions Lead for Cell Therapy manufacturing will engage in collaboration with multi-functional teams and technology product lines, employing agile methodologies to implement NextGen solutions across automation platforms deployed in Raritan. A robust business background in operational technology and manufacturing execution systems is essential for this role.
#Li-Hybrid
Key Responsibilities:
- Lead quality commitments including change controls, non-conformances, and corrective/preventive actions for supply chain systems (e.g. MES, PIMS, DCS/SCADA, and EMS). Support root cause analysis and after action reviews, while developing effective technical solutions. Serve as the SPOC and SME from the technology team for quality commitments.
- Lead planning activities for MES (KPS PAS-X) and automation builds, release sprints, user demonstrations, and cutover activities. Evaluate new technologies and digital capabilities in partnership with business and IT teams. Support short-term software release planning and the implementation of an end-to-end technology systems roadmap.
- Provide expert-level technical project management for business operations and CapEX and OpEX initiatives within Raritan's operational technology portfolio. Effectively manage interdependency controls and project risk.
- Serve as the Local Business Product Owner for Kneat Document Validation Software, responsible for administrative tasks and implementing test protocols scripts for MES and automation systems (e.g. CTP, UAR, IQ/OQ and PQ). Drive SDLC process improvements.
- Author, review, and approve local automation documentation (e.g., standard operating procedures and design specifications) per GDP. Ensure alignment to global procedures. Manage automation training curricula material within LMS and conduct regular instructor-led training sessions.
- Collaborate multi-functionally with Operations, Manufacturing Science and Technology, Quality, IT, Facilities, and Global within both Johnson & Johnson and Legend Biotech.
- Support the Raritan site readiness for FDA and health authority audits, as necessary
Qualifications
Education:
- A minimum of a Bachelor’s degree is required. A Master’s degree in Systems Engineering, Computer Science, or a related field; advanced degrees (e.g., MBA) is preferred.
Experience:
Required:
- A minimum 6 years of relevant professional experience within a regulated, multi-functional pharmaceutical or biotechnology manufacturing environment is required.
- In-depth technical knowledge within MES (KPS PAS-X) development lifecycle and automation engineering roles (e.g. PIMS OSI-PI).
- Extensive experience supporting and fulfilling quality commitments (e.g. CC, NC, and CAPA records) per GxP and documented in QMS, such as Comet or TrackWise.
- Practical knowledge of ISA-95/88 standards, FDA GxP, 21 CFR Part 11, EU Annex 11, ISPE GAMP-5, and the Software Development Lifecycle, particularly in the pharmaceutical or manufacturing sectors, is required.
- A demonstrated record of leading continuous improvement projects and successful implementations of MES and automation solutions that drive business excellence. Must have a strong emphasis on driving technology adoption.
- Excellent interpersonal skills (written, verbal, and presentation). Must have the ability to influence and make data-driven decisions according to the J&J Credo.
Preferred:
- Experience with Cell Therapy Chain of Custody (COC) and Chain of Identity (COI) systems.
- Certification in Process and/or Project Management, e.g., Lean Six Sigma, PMP, Agile PM.
- Knowledge of Data Lake and Data Visualization Tools; e.g, PowerBI, Tableau, PI Vision.
- Experience engaging in FDA and/or Health Authority regulatory audits and inspections.
Other:
- This position is required to be on site 3 days per week and requires up to 5% domestic and international travel, based on business needs
Why Join Us? This role presents a unique opportunity to lead transformative initiatives in Cell Therapy Supply Chain Systems and Automation, promoting standard processes in technology solutions management and supporting business objectives. If you're a visionary leader passionate about operational excellence and continuous improvement, we invite you to be part of our transformative journey. This position is a great opportunity for high-potential talent looking for accelerated development and providing hope to cancer patients.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$100,000 to $172,500Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company’s long-term incentive program. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.