Change Control Specialist, CAR-T
- Raritan, NJ
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Change Control Specialist, CAR-T.
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 Change Control Specialist, CAR-T is responsible for change control support for the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Support process changes arising from updates to materials, excipients or finished goods requirements
• Support efforts to establish and streamline the site change control process
• Act as change control champion for operations by being responsible for the change control from Initiation through completion
• Participate in global forums/team meetings for Change control
• Run reports and conduct data analysis to support establishment and monitoring of change control for operations.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
• A minimum of a Bachelor's degree is required, preferably with a focus in Engineering, Biology, or Chemistry.
Experience and Skills:
• A minimum of four (4) years of related experience in a regulated and/or research environment is required.
• Experience in the Pharmaceuticals or related industry is required.
• Strong working knowledge of current Good Manufacturing Practices (cGMP's), initiating and executing change controls is required.
• Proficiency in English (verbal and written), strong communication skills and the ability to influence at all levels are required.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.
• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
• Prior experience with CAR-T and/or cell therapy is preferred.
• Demonstrated technical leadership within pharmaceutical or similar environment is preferred.
• Experience with the start-up of new biopharmaceutical manufacturing facilities is preferred.
• Experience with Trackwise or equivalent systems is preferred
• This position will be based in Raritan, NJ and requires up to 10% of domestic travel
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.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc. (6062)
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