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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 Management

Job Sub** **Function:

Technology Operations Support

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, 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 seeking the best talent for a Technical Owner Cell Science, Advanced Therapies to be located in Raritan, NJ.

Purpose:

The Technical Owner is overseeing the American apheresis and cryopreservation network as single point of contact for all technical aspects of technical operations at our most modern sites in the global network (internally and externally). In addition, the holder of the role is responsible for driving the implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Cross-functional partnership with R&D, Quality, and Manufacturing will be required to ensure processes meet the needs of today and tomorrow. Acting as the primary SME for cellular starting materials, overseeing both cryopreservation and apheresis processes, the Technical Owner will lead relationships with operational teams during implementation of technical innovations. The successful candidate is therefore able to appropriately balance requirements with innovation and speed at cell processing sites as the team is driving multiple scientific and technical programs in a highly regulated environment. The capability to interact both with physicians and technical personnel at cell processing sites globally is essential for this role.

The ability to navigate within a global network and collaborate effectively with internal and external partners will be key to driving critical programs to successful completion. Up-to-date knowledge of industry standards and regulatory requirements related to cellular therapies are critical.

Key Responsibilities:

+ Lead the local implementation of process changes

+ Contribute to digitalization initiatives

+ Collaborate with US manufacturing sites resolving shared technical challenges and harmonizing processes across the sites

+ Drive the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans relating to cellular starting materials

+ Collaborate with R&D, site functions and finance to identify technical improvement or cost reduction opportunities

+ Lead innovation opportunities, build project business cases and prioritize projects (starting material-related)

+ Provide cryopreservation process training to operators to ensure global process consistency and retain knowledge within the CPC

+ Proactively monitor apheresis and cryopreservation processes and performance to detect trends and develop mitigation plans

+ Perform technical assessments for non-conformances related to starting materials and support failure investigations (incl. escalation of quality or compliance events)

+ Present to health authorities during inspections

+ Maintain a robust technical support network related to cell sciences, new technologies, automation, change management and tech transfers

+ Identify and oversee implementation (in partnership with R&D) of lifecycle management, new technology and process improvement projects in our global cryopreservation network to improve robustness, scalability and cycle time performance

+ Author and review technical reports, source documentation

+ Create, maintain, and upgrade cellular starting material knowledge as an element of the value chain knowledge infrastructure

Qualifications:

+ A Master’s or Ph.D. degree, preferably in a biological or biomedical technical discipline is required and a minimum of 7 years of experience in a pharma environment is required

+ In-depth knowledge of the apheresis and cryopreservation processes is critical

+ Excellent knowledge of cGMP and GTP is required

+ Project Management skills and the ability to interface cross-functionally with other expertise areas including clinical and operational personnel are required

+ Understanding of drug development and submission requirements is required

+ Manufacturing and logistics understanding/experience is preferred

+ Ability to work independently and in a matrixed team environment is required

+ Has demonstrated to be able to make decisions independently, innovate and is strategic thinker with broad vision

+ Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required

+ Experienced quality assurance/compliance mindset is required

+ Has a data driven mindset and acts accordingly

+ Fully independent, self-directed and physically able to work on-site

+ Travel may be required up to 10% of time

+ Eligible to work in the USA

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 vertebras and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100,000 to $172,500

Additional 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)). • 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. https://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.