Quality Control Analyst, CART Critical Reagents - Johnson and Johnson

Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control Analyst, CAR-T Critical Reagents! (2nd Shift). This position will be located in Raritan, NJ

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into 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.
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
• Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Perform peer review of laboratory data.
• Collaborate and coordinate with testing laboratories to obtain the data necessary to prepare documentation and issue Certificate of Analysis.
• Author and update SOPs, WIs and Protocols to support project using the Document Management System
• Maintain individual training completion in a compliant state
• 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

Education:

A minimum of a Bachelor's degree in a Scientific or related field is required
Required:

• A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent.
• Understanding of analytical data generated from performing biological and biochemical analytical techniques such as cell-based assays.
• Ability to manage an individual project with guidance from supervision/management.
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Excellent written and oral communication skills.

Preferred:

• Detailed knowledge of analytical technologies used in the QC laboratory (CAR-T experience).
• Experience in reagent qualification.
• Skilled in performing basic and some advanced testing within the functional laboratory.
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC.

Other:

• This position requires up to 10 % travel to regional sites.
• This role will be 2nd shift 2pm- 10:30pm
  The anticipated base pay range for this position is 61000 to 97750.

  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. https://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.

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.