Quality Control Car-T Manager

Janssen Pharmaceuticals Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control CAR-T Manager!

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 cell therapy products? Apply today for this exciting chance to be part of the #CAR-T team!

The QC CAR-T Manager is responsible for day-to-day Quality Control activities oversight 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.

Key Responsibilities:

• Provide expertise in troubleshooting complex laboratory issues and demonstrate strong reasoning skills in support of ongoing laboratory investigations.
• Ensure adherence in support Drug Product release testing cycle times.
• Review/approve documents as a QC department subject matter expert (SME).
• Adjust roles and responsibilities of department to meet business needs.
• Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, and Maintenance to support business needs.
• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs, and change controls.
• Manage Supervisors and provide operational guidance to scheduling activities.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Communicate department objectives and metrics to staff.
• Contribute to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards.
• Manage departmental budget and resources; prepares staffing plans.
• Ensure accuracy and completeness of executed analytical method transfer activities.
• Support internal and Health Authority audits and inspections.

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent University degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, or related scientific field is preferred

Experience and Skills:

Required:

• Experience leading, coaching, or supervising direct or indirect personnel or teams
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Minimum 8 years of relevant work experience
• Experience in Cell and/or Gene therapy or Biologics
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Document Practices (GDP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems

Preferred:

• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing
• Experience with LIMs and SAP or equivalent systems
• Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and/or 610
• Knowledge and experience in CAR-T cell therapy, T cell biology, and/or immunology

Other:

• Requires up to 5% of domestic travel
• Requires ability to occasionally lift up to 20 pounds
• Requires flexibility to provide occasional support on the weekends or weeknights as needed

The anticipated base pay range for this position is $97,000 to $166,750.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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 .