Johnson & Johnson is currently seeking a Sr. Scientist/Engineer, ATSC ExM MS&T to join our TEAM!
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
Are you interested in making a difference in a growing company thriving on a diverse culture, celebrating the uniqueness of our employees, and committed to inclusion? Apply today for this phenomenal opportunity!
The Scientist/Senior Scientist, External Manufacturing MS&T supports manufacturing activities for the Advanced Therapies Supply Chain organization within the third-party manufacturing site. This includes executing robust strategies to maintain the validated state of cell and gene therapy processes while implementing lifecycle management initiatives related to new technologies, automation, technology transfer, etc. This role serves as a person-in-plant in support of routine manufacturing, aids in change management activities at the third party manufacturing site, and supports complex deviations. This is a critical role supporting the site's technical, supply, and compliance related objectives. This position supports/participates in the virtual plant team and actively collaborates with Quality, Supply Chain, and Growth & Partnerships functions.
Key Responsibilities:
- Provide manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, and process improvement projects.
- Act as receiving site for any lifecycle process technology transfers including process qualification/comparability campaigns, process risk assessments, process control strategies and new process training.
- Provide technical support to regulatory filings, regulatory inspections, and health authority questions.
- In collaboration with other functions, supports the development and implementation of fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for deviation investigations, technology transfer, process monitoring, and other relevant areas.
- Support process monitoring and process data analysis, troubleshooting, facility fit assessments of new processes into the existing manufacturing plant, assessments and writing of technical documents and technical optimization/implementation projects
- Translate strategic product roadmaps to detailed execution plans for programs to deliver on target outcomes to enhance the lifecycle of the product.
- Drive continuous improvement and foster an operational excellence culture to enhance productivity and efficiency of operations
- This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Qualifications
Education:
- A minimum of a bachelor's and/or equivalent degree is required; focused degree in Engineering/ Science, preferred
Experience and Skills:
Required:
- 6 Years Biotech/ Pharmaceutical experience or equivalent industry experience.
- Prior work experience in a manufacturing environment
- Knowledge of good manufacturing practices (GMP) and documentation.
- Ability to work in a cleanroom, laboratory, and office setting,
- Excellent judgment. able to prioritize and decide appropriate courses of actions.
- Effective at implementing decisions, troubleshooting and problem-solving skills in a fast-paced environment.
- Hands-on experience and knowledge in manufacturing sciences and operations support, technology transfer, process comparability process monitoring, change management, cGMP compliance, and advanced therapies (ie. cell/gene therapy products, vaccines) product regulatory and validation requirements
Preferred:
- Experience in a Cell/Gene Therapy cGMP manufacturing setting
- Working knowledge of Lean/Continuous improvement concepts
Other:
- Ability to travel 50% of the time between 2 site locations (Morris Plains and Raritan), is required
The anticipated base pay range for this position is 91000 to 147200.
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. • Please use the following language:
- 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. 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."