Janssen Pharmaceuticals Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II (QPIP), CAR-T Manufacturing.

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 QA Associate II is a Quality Person in the Plant (QPIP) and is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Work with Process Development team and Operations organization to optimally transfer process to cGMP facility to manufacture products.
• Support drafting of standard operating procedures and batch records.
• Approve printed documents prior to use on the manufacturing floor.
• Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
• Real time review of all documentation and reporting in support of process unit operations.
• Support material release in SAP for In-house reagents.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival
• Monitor warehouse, manufacturing, and manufacturing support activities for CG MP compliance through spot checks/internal audits.
• Other duties will be assigned, as the need arises.
• Support clean room activities.
• Provider QA shop floor support for extended periods of time.
• Support the Shop Floor Order QPIP review and Closure process for completed batches and In House reagents/intermediates.
• Responsibilities will include but not limited to tasks mentioned above.

Qualifications

Education:

• Minimum of a bachelor’s degree required ; focused degree in Science, Engineering, or equivalent technical field preferred.

Experience:

Required:

• A minimum 2 years of Experience in Quality Assurance, within manufacturing of CAR-T manufacturing environment/Cell therapy/Gene therapy.
• Relevant working Experience with aseptic processing in ISO 5 clean room and/or biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU mentorship related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Excellent written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to collaborate well with team members, customers, and peers.
• Ability to manage conflict and issues that arise with internal or external customers.
• Ability to prioritize multiple tasks on same time.

Preferred:

• Familiarity with SAP, MES (electronic batch records), TrackWise (quality event management), or equivalent systems.

Other:

• Ability and flexibility to work 10-hour shifts between the operational hours of 2:00 PM – 12:30 AM (Wednesday - Saturday), and provide occasional support including nights, weekends, or other shifts with little or no prior notice, required
• Ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc.) and to detail observations during manufacturing, require

The anticipated base pay range for this position is $57,500- $92,575.

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 .]