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:

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 Assistant Scientist to be in Spring House, PA.

The candidate for this position will join a fast-paced development organization. The manufacturing operations team is responsible for production of autologous CAR-T therapies, working closely with the broader API team to prepare new technologies for GMP readiness.

Key Responsibilities:

• Perform process unit operations according to standard operating procedures and batch records.
• Participate in tech transfer of the process from the development lab to cGMP facility, qualification, and validation of the facility and equipment.
• Assist in the draft of standard operating procedures and batch records.
• Work with Process Development team and Quality organization to successfully transfer processes to cGMP facility to manufacture products.
• Perform tasks in compliance with the safety policies, quality systems and cGMP requirement.
• Other duties will be assigned, as appropriate.
• Occasional weekend work is required.

Qualifications:

Required:

• Bachelor’s Degree in Biological Science
• At least a year of relevant laboratory experience. Experience in a cGMP environment is preferred.
• Knowledge of cGMP regulations and FDA guidance, and other external regulatory authorities related to manufacturing of cell based products (ATMPs and Annex 1).
• Understanding of Aseptic processes in a clean room environment.
• Good written and verbal communication skills are required.
• Ability to handle human derived materials in BSL-2 containment areas

Preferred:

• Aseptic gowning and processing in clean room and ISO 5 biosafety cabinets

• Experience with Cell expansion and cell washing processes using automated equipment.

• Experience with MES (Electronic documentation) and ERP.

• Experience with equipment qualification or data integrity.

• Experience with any of Robotics, Automated control systems, computer coding or process monitoring.

• Able to lift a minimum of 25 lbs and able to stand for a long period of time.

• Ability to pay attention to details and follow procedures.

Other:

• The candidate must be highly organized and capable of working in a flexible team environment with a positive attitude under some supervision. Must maintain written records of work in the form of batch records, notebooks, technical reports and protocols. Ability to summarize and present results. Experience working in collaborations is a must.
• Up to 10% travel is possible.

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.

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.