Manager, CAR-T Investigations

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, CAR-T Investigations 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.

The Manager, CAR-T Investigations is responsible for the daily management of the Investigation Lifecycle as well as identifying and implementing process improvements to maintain compliance and reduce complexity and investigation cycle time.

Key Responsibilities:

• Lead and build a team to support the investigation and resolution of deviations and atypical events
• Lead sophisticated manufacturing investigations quickly driving to root cause to meet critical release windows and provide technical expertise to help identify true root cause of investigations and assess product quality impact
• Establish tools and metrics to supervise and streamline investigations, change implementation processes, and partner with all Functional Cells and COE’s to implement process improvements.
• Recommend corrective/preventative measures sought at improving compliance and reducing repeat occurrences and technical feasibility of proposed changes
• Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Track deviations, events and key process parameters and provides reports to management on trending, and status by maintaining various databases of production information.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA) and assure regulatory compliance
• Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
• Review and approve SOP and Batch record revisions relating to investigations

Qualifications

Education:

• A minimum of a bachelors' degree in a Scientific, Business or Engineering focus
• MBA is preferred

Experience and Skills:

Required:

• A minimum of eight (8) years of professional relevant business experience
• A minimum of four (4) years supporting investigations and/or change management in a highly regulated environment is required.
• Experience with internal and external regulatory audits is preferred
• Experience with Deviation Management Systems, such as eLIMS, Trackwise, Maximo, EMS, BMS (Building Management Systems), or SAP
• Excellent written and verbal communication skill are required
• Experience in directly leading a team

Preferred:

• Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations is required.
• Ability to apply various standard programs for data entry and word processing is preferred.
• Ability to respond to critical inquiries or complaints from top managers, regulatory agencies, or members of the business community is required.

Other:

• This position will require up to 10% of travel
• The anticipated pay range will be from $92,000 to $142,000

As you are aware, COVID-19 Vaccine Mandates are beginning to roll out around the globe. In partnership with Legal, Communications, and other stakeholders, we are sharing the below approved language for job postings in multiple locations (both with and without vaccine mandates). With vaccine mandates at various stages based on country regulations, the language below should be used when posting a role in multiple locations. When posting a role in a single country location with a Vaccine Mandate in place (i.e., the US/PR, Canada, ANZ, etc.), approved country-specific Vaccine Mandate language should be used.

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, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, 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. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

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 .]

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