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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:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Spring House, Pennsylvania, 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 an MSAT Sr. Principal Scientist that will be based in Spring House, PA or Horsham, PA.

Purpose:

The Sr. 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. In this role, he/she will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow.

The Sr. 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:

+ Lead and coordinate biopharmaceutical manufacturing projects, including but not limited to tech transfer and process validation activities.

+ Utilize detailed technical knowledge of manufacturing unit operations.

+ Leading cross-functional risk assessments.

+ Conduct complex investigations and FMEA for manufacturing or life-cycle management.

+ Demonstrate strong communication and organizational skills to effectively influence and collaborate with peers, superiors, and external partners in a dynamic, highly matrixed environment.

Qualifications:

+ Bachelor’s degree in biotechnology, chemistry, engineering, or related areas. Master’s and PhD degrees are a plus with 8-10 years of experience.

+ Demonstrated experience in biopharmaceutical manufacturing across all stages of the product life cycle development.

+ Principal Scientist level will require proven experience in the biopharmaceutical development or manufacturing arena.

+ 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.

+ Fluent in written and spoken English

+ 10-25% travel may be required, depending on project needs.

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 vertebras and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & 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 ([email protected]) or contact AskGS to be directed to your accommodation resource.