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:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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-medicineJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T! This position will be located in Raritan, NJ!

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/.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

The Quality Control Analyst is responsible for completing QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Perform peer review/approval of laboratory data.
• Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
• Build, review, and approve relevant QC documents, SOPs, and WIs.

Qualifications:

Education:

• Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred

Experience and Skills:

Required:

• A minimum of 2 years of relevant work experience
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, ELISA, Cell Culture, and/or Potency assays
• Experience with Manual Sample Processing
• Excellent written and verbal communication skills

Preferred:

• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Work experience in Cell and/or Gene Therapy or Biologics
• Experience with LIMs and SAP or equivalent systems

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 8AM - 6PM, Sunday- Monday, and provide occasional support for other shifts
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
• This position may require up to 10% of domestic and international travel

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

#CAR-T

The anticipated base pay range for this position is:

$69, 500-$102, 350

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.