描述
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Microbiology Specialist III, CAR-T Manufacturing 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.
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 QA Microbiology Specialist III, CAR-T Manufacturing is responsible for evaluating aseptic behavior on the manufacturing floor, developing trends and analytics for environmental monitoring and aseptic behavior data, developing and implementing aseptic procedures and methods, supporting quality investigations, as well as leading various QA microbiology department projects.
Key Responsibilities:
- Develop, track, maintain, and deliver accurate data, metrics, and reports to support CAR-T manufacturing environment locally and in collaboration with other global Advanced Therapy Medicinal Products (ATMP) manufacturing sites.
- Support continuous optimization of the microbiological control strategy maintaining consistency with cGMP and Janssen requirements.
- Communicate key critical inputs to site environmental monitoring program to site stakeholders.
- Support Process microbiological investigations, completion of corrective and preventive actions, internal/external audits and Quality risk assessments.
- Support Aseptic Process Simulation (APS) team with execution of site qualification activities.
- Maintain working knowledge of regulatory requirements, and applicable Pharmacopeia while remaining current in on-the-job training requirements.
- Identify risks and opportunities in relation to process, contamination, and cross-contamination associated with the manufacturing environment and drive follow-up initiatives for improvement in close collaboration with operators, QA, QC and operations management.
- Conduct Aseptic Training, Aseptic Process Observation and manufacturing floor surveillance.
資格
- Minimum of a Bachelor’s or equivalent University degree required; Engineering, Science, or equivalent technical subject area preferred
Experience and Skills:
Required:
- Minimum four (4) years of relevant work experience
- Microbiological, Biological, and/or Pharmaceutical industry experience
- Knowledge of or experience with aseptic processing in ISO 5 biosafety cabinets
- Experience working with Quality systems (eLIMS or Trackwise)
- Proficient written and verbal communication skills, with the ability to effectively summarize and present results
- Previous experience with data analytics tools (such as Tableau, Power BI, etc).
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:
- The anticipated salary for this role will be between $75,000 and $110,000.
- Requires up to 5% 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.
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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