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 to join our Team! **Position summary:** Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology organization! We are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team! 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. **Key Responsibilities:** + 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** **Education:** + Minimum of a Bachelor’s Degree or equivalent University degree with a focus in Science and/or Engineering is required. Masters/PhD degree in Science and/or Engineering is preferred. **Experience and Skills:** **Required:** + 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. 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. 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.