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Janssen Pharmaceuticals Inc. a member of Johnson & Johnsons Family of Companies is recruiting for a Senior Supervisor Quality Assurance Microbiology - CAR-T Manufacturing. 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 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 teams 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 Bachelors 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

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 & 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 external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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Manager