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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Malvern, 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 a Scientist, Process to be located in Malvern, PA.

You will be responsible for:

• Leading equipment qualification activities in compliance with industry and regulatory standards to support Fill/Finish and R&D.

• Facilitating and participating in cross -functional technical discussions, resolving issues with equipment suppliers, project teams, and quality partners.

• Designing and deploying automation solutions across manufacturing unit operations to drive operational excellence and innovation.

• Advancing scientific understanding of process impacts on drug product quality, ensuring alignment with internal standards for scientific rigor and consistency.

• Supporting and leading Fill/Finish operations, including Lead Stability Development batch manufacturing, with a focus on continuous improvement and production support.

• Developing process engineering capabilities, including the use of multi-physics modeling software and statistical data analysis to support process optimization.

Qualifications / Requirements:

Education:

• A minimum of a Bachelor's degree in System or Electrical Engineering with 3+ years of experience (e.g., co-op or industry) is required. An advanced degree (Master's) with 2+ years of experience is preferred.

Experience and Skills:

• Extensive experience in GMP engineering runs, including process optimization, troubleshooting, and data analysis to support tech transfer and scale-up activities is required.

• Demonstrated experience working with Contract Development and Manufacturing Organizations (CDMOs), including oversight of outsourced manufacturing operations, technical transfer, and alignment with internal quality and regulatory standards is required.

• Strong background in Fill/Finish operations, including aseptic processing, formulation, filling, visual inspection, and packaging of biologics is required.

• Proven expertise in GxP automation equipment, including commissioning, qualification (IQ/OQ), and life-cycle management of manufacturing systems and instrumentation is preferred.

• Proficiency in automation control systems, sensors and signal conditioning, and circuit design/analysis for GMP environments is preferred.

• In-depth technical understanding of biologics, including monoclonal antibodies (mAbs), gene therapies, and cell therapies, with hands-on experience in regulated pharmaceutical manufacturing is preferred.

• Strong knowledge of GMP compliance and regulatory expectations, with the ability to interpret and apply guidelines across manufacturing and quality operations is preferred.

• Excellent communication and leadership skills, with a track record of effectively delivering information across multi-functional teams and global sites is preferred.

Other:

• This role will be based in Malvern, PA (M20).

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Coaching, Collaborating, Conducting Experiments, Data Quality, Drug Discovery Development, Molecular Diagnostics, Patent Applications, Pharmacogenetics, Report Writing, Research Documents, Scientific Research, Technologically Savvy, Written Expression

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.