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:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America, US121 NJ Raritan - 1000 Highway 202 S

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 Senior Principal Scientist, MSAT – Advanced Therapies that can be in either Raritan, NJ, Spring House, PA or Horsham, PA.

Purpose:

The Senior Principal Scientist we are seeking will be responsible for leading Advanced Therapies manufacturing projects, including product introduction, tech transfer, validation, and providing routine manufacturing support. He/She will also be responsible for projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. In this role, he/she will partner with R& D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow.

The Senior Principal Scientist can shape, can work in close collaboration with other roles, and must have strong communication skills to influence other functions/levels outside of own group. In this role you will effectively lead global and cross organizational teams to generally attain desired results for all parties. Strong knowledge of cell and gene manufacturing processes is a must. Hands-on experience in both R& D and Manufacturing Operations is highly desirable. Proven experience with technical documentation will be required.

Key Responsibilities:

• Acts independently to ensure that Supply Chain Manufacturing Engineering project plans are comprehensively reviewed, implemented, and completed on schedule and within budget.

• Consults on critical detailed engineering project schematics that will lead to improved performance and efficiencies by capitalizing on standard project management tools.

• Evaluates relevant manufacturing data into broadly-understandable terms to communicate project progress with leadersihp.

• Guides the effective and efficient use of project engineering tools and techniques to solve opportunities.

• Checks status on assigned projects in various formats to various organizational levels.

• Guides junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision.

• Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.Lead and coordinate biopharmaceutical manufacturing projects, including but not limited to tech transfer and process validation activities.

Qualifications:

Required:
• Bachelor degree in biotechnology, chemistry, engineering, or related area. Master’s and PhD degree is a plus with Demonstrated experience in biopharmaceutical manufacturing across all stages of the product life cycle development.
• Proven experience in the biopharmaceutical development or manufacturing for 8-10 years of experience.
• Detailed technical knowledge of manufacturing site unit operations with a preference for cell and gene therapy manufacturing.
• Experience leading the coordination of tech transfer activities and technical services.
• Experience leading the coordination of process validation activities.
• Strong communication and interpersonal skills, with the ability to work independently and in a team environment.
• Experience leading complex investigations using a variety of RCA tools.
• Experience leading FMEAs for process change, technology transfer and material qualification.
• Good knowledge of GMP, Q& C and regulatory requirements.
• Ability to influence and lead peers, superiors, and external partners.
• Experience working in a large, highly matrixed environment.
• Flexibility to adapt to changing situations and priorities and to provide problem resolution.
• Excellent organizational skills across multiple work streams with the ability to plan and anticipate deadlines and deliverables.

Preferred:
• Experience with manufacturing scale out, including capacity protocols and execution.
• Experience with aseptic processing simulations, process closure and Annex 1 requirements.
• Experience with MES, LIMs, data automation IT architecture is a plus.
• Experience with facility design, layouts and essential utilities is a plus.

Other:
• Fluent in written and spoken English
• 10-25% travel may be required, depending on project needs.
• 15-30% of occasional person in plant responsibilities.

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:

$137, 000 to $235, 750

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)). 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. 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.