Technical Owner, MSAT

Johnson & Johnson • Full-time • US121 NJ Raritan - 1000 Highway 202 S, United States of America • 3w ago

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:

Project/Program Management Group

Job Sub Function:

Project/Program Management

Job Category:

Professional

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 searching for the best talent for a Technical Owner, MSAT to be in Raritan, NJ.

Purpose:

The Technical Owner serves as part of the Global Technical Team, reporting to the Global Process Owner within the Advanced Therapies Manufacturing Science and Technology Organization. They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow.

You will be responsible for:

Partner cross-functionally with the Value Chain Team (VCT), owning the coordination of all technical activities.
Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis
Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans
Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process)
Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)
Proactively monitor technical process and product performance to detect trends and develop mitigation plans
Democratize process information across sites
Author “why” modules and train operations/quality on scientific basis of the process
Support failure investigations issues escalation of quality or compliance events)
Execute or follow-up on execution of technical projects
Present to health authorities during inspections
Develop validation approaches and technical strategy for implementation of key initiatives
Maintain a robust technical support network related to lifecycle management, new technologies, automation, comparability, change management and tech transfers for product
Identify and oversee implementation (in partnership with R&D) of lifecycle management, new technology and automation projects at the manufacturing sites to improve robustness, scalability and cost/cycle time/quality performance for approved products
Partner cross-functionally and champion to develop strategies for comparability exercises to enable change implementation
Ensure technical and manufacturing product requirements are addressed throughout lifecycle of new solutions
Author and review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions
Apply the science-based risk approach and regulatory intelligence
Manage a multi-disciplinary team of technical experts across technical/operations/quality functions at the manufacturing site
Create, maintain, and upgrade product technical knowledge as an element of the value chain knowledge infrastructure
Perform internal and external benchmarking activities
Reviews technical product & process risk profiles and criticality analysis
This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

Autonomy and complexity:

Represent the area for site wide/global projects as required.
Lead troubleshooting of routine manufacturing processes.
Endlessly curious, seeking to understand the “why” behind complex scientific topics
Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements
· Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines

Qualifications:

Required:

A minimum Bachelors Degree or equivalent University degree with a focus Science and/or Engineering is required. Masters/PhD degree in Science and/or Engineering is preferred.
Minimum 8 Years of relevant experience in Biotech/ Pharmaceutical industry experience
Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. cell/gene therapy products, vaccines, or any other large molecule products)
Proficiency in Microsoft Office (ie, Excel) and Statistical Packages (JMP, Minitab, etc)

Preferred:

Knowledge and experience in cell and gene therapy manufacturing processes
Experience with GMP/quality considerations for commercial manufacturing
Experience in data analytics/sciences and process automation
Expert knowledge of evolving ATMP health authority expectations/regulations
Experience leading the coordination of tech transfer activities and technical services

Other:

Works in an international environment across different time zones
Requires up to 20% domestic and/or international travel

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 :

$120,000 to $207,000

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. • Subject to the terms of their respective plans, employees and/or eligible dependents are 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. • Subject to the terms of their respective plans, employees are 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. • For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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