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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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

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 searching for the best talent for a Technical Lead on the Product Stewardship MS&T Team !

The Manufacturing Science and Technology organization is 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.

Summary

The Technical Lead, Advanced Therapies Supply Chain MS&T supports the Raritan MS&T team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving. They will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Key Responsibilities

• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.

• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.

• Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.

• Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.

• Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment.

• Work cross-functionally across MS&T and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.

• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.

• Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing.

• Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.

• 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 degree or equivalent University degree is required, degree in Engineering and advanced degree is preferred.

Experience and Skills:

Required:

• Minimum 6 yrs of operations experience within a cGMP environment in biotech/biopharma industry with a minimum 2 yrs experience in Cell / Gene therapy cGMP manufacturing experience is required or minimum 8 yrs of operations experience within a cGMP environment with a Cell/Gene Therapy CGMP manufacturing experience is preferred.

• Experience in building strong partnerships and effectively integrating with external collaborators to drive projects/programs forward in a matrixed environment.

• An ability to build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.

• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.

• Clear and succinct verbal and written communication skills.

• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously

• Integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.

Other:

• Ability and flexibility to accommodate changes in the schedule and working in other shifts including evenings and weekends as required by the manufacturing process.

• Ability to accommodate unplanned overtime on little to no prior notice.

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 :

USD $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. 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.