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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Supervisor, QA Micro Aseptic Performance - CAR-T Manufacturing 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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The CAR-T Quality department leads all aspects of Quality (QA/QC), in support of the Raritan CAR-T Janssen Supply Chain (JSC) site, in compliance with established cGMP and J& J requirements. The Senior Supervisor will provide oversight for a wide range of activities including hiring, development and performance management of staff, evaluating aseptic behavior on the manufacturing floor, developing and implementing aseptic procedures and methods, supporting quality investigations, as well as leading various QA microbiology department projects.

Key Responsibilities:

• Manage Aseptic Process Observation program and schedule manufacturing floor surveillance.
• Demonstrate aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Support continuous optimization of the microbiological control strategy maintaining consistency with cGMP and Janssen requirements.
• Communicate key critical inputs to site environmental monitoring program.
• Actively support Process microbiological investigations, completion of corrective and preventive actions, internal/external audits and Quality risk assessments.
• Support the identification of risks and opportunities in relation to contamination control in the manufacturing environment and assist in follow-up initiatives for improvement in close collaboration with operators, QC and operations management; perform walkdowns to monitor the team’s performance.
• Support APS team regarding strategy and review/approval of site qualification activities.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable Pharmacopeia while remaining current in on-the-job training requirements.

Qualifications:

Education:

• Minimum of a Bachelor’s or equivalent university degree required; Engineering, Science, or equivalent technical subject area preferred

Experience and Skills:

Required:

• Minimum six (6) years of relevant work experience
• Microbiological, Biological, and/or Pharmaceutical industry experience
• Knowledge of or experience with aseptic processing in ISO 5 biosafety cabinets
• People management or leadership experience (direct or indirect reports)
• Experience working with Quality systems
• Proficient written and verbal communication skills, with the ability to effectively summarize and present results

Preferred:

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices (GTP)
• Experience working in an aseptic manufacturing facility
• Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development

Other:

• Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
• Requires up to 5% domestic travel

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.

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.

The anticipated base pay range for this position is:

$91, 000-$147, 200

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits