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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:

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 Supervisor, Quality Control - 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 tomorrow's breakthroughs and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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!

Position Summary:

The QC Supervisor is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. They are responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws; responsibilities include interviewing, hiring, performance review, rewarding and disciplining employees, addressing complaints, resolving conflict, and supporting internal and external audits. They will typically guide daily work activities of 10-12 direct staff within a functional laboratory of the Quality Control department.

Key Responsibilities:

• Manage analyst schedule to support Drug Product testing

• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards

• Review/approve documents as a QC department subject matter expert (SME)

• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls

• Ensure accuracy and completeness of executed analytical method transfer activities

• Set testing priorities and manage work assignments

• Maintain individual training completion in a compliant state

• Mentor, train and supervise quality control staff

• Evaluate performance and provides opportunities for growth.

• Communicate department objectives and metrics

• Support internal and Health Authority audits

• Support audit related investigations

Qualifications:

Education:

A Minimum of a Bachelor’s or equivalent University degree is required.

Experience and Skills:

Required:

• Minimum four (4) years of relevant work experience

• Proficient knowledge of analytical technologies used in a Quality Control laboratory and method transfer

• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems

• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and/or 610

• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing

Preferred:

• Experience in leading, coaching, or supervising direct personnel or teams

• Experience in Cell and Gene therapy

• Experience with cellular and/or molecular based techniques including qPCR, Flow Cytometry, Potency assays, ELISA, and/or cell cultures

• Experience with LIMs and SAP or equivalent systems

Other:

• The shift will be Sunday-Wednesday 7am-5pm or 8am-6pm EST.

• Requires ability and flexibility to provide occasional support on the weekends or other shifts if needed

• Requires ability to occasionally lift up to 20 pounds

• Requires up to 5% of domestic travel

• This position has an estimated annual salary of 77,000- 124,200 $USD.

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

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 :

77,000- 124,200 $USD

Additional Description for Pay Transparency:

• This position has an estimated annual salary of 77,000- 124,200 $USD. 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