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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for a Quality Control Analyst, CAR-T Critical Reagents! This position will be located in Raritan, NJ.

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Johnson & Johnson and Legend Biotech USA Inc, have entered a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

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 (QC) Analyst Critical Reagents is responsible for preparing and conducting testing of critical reagents used by the QC laboratories. They are responsible for ensuring testing is completed in adherence with all applicable procedures, standards, and GMP regulations.

Key Responsibilities:

• Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
• Perform analytical testing in compliance with all applicable procedures, GMP, and GDP regulations
• Ensure a safe work environment by following guidelines in environmental, health, and safety regulations
• Perform peer review of laboratory data
• Collaborate and coordinate with testing laboratories to acquire the data necessary to prepare documentation and issue Certificate of Analysis
• Author and update SOPs, WIs, and Protocols using the Document Management System
• Support laboratory related investigation records and CAPAs
• Assist in the execution of internal audits
• Provide input to functional laboratory meetings
• Provide input and take actions as a QC representative at cross-functional meetings

Qualifications:

Education:

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

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Excellent written and verbal communication skills

Preferred:

• Experience in reagent qualification
• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Basic knowledge of compendial (e.g., USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Work experience in Cell and/or Gene Therapy

Other:

• Requires ability and flexibility to work 8-hour shift between the operational hours of 8: 00am - 4: 00pm (Monday - Friday), and provide occasional support on the weekends or other shifts.
• Requires up to 10% domestic travel to regional sites.

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
• Work, Personal and Family Time - up to 40 hours per calendar year

The anticipated base pay range for this position is 70, 000- 126, 000 USD$.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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.

The anticipated base pay range for this position is:

70, 000- 126, 000 USD$

Additional Description for Pay Transparency:

• 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 - Work, Personal and Family Time - up to 40 hours per calendar year