Join Our Crew

Responsibilities Include

Main Responsibilities:

• Provide “Person-in-Plant” (PIP) support and oversight of CART drug product manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs)
• Possess in-depth knowledge of the manufacturing process, including critical process parameters, risks and provide technical oversight and guidance.
• Serve as a communication bridge between the Cabaletta and the contract manufacturer, address concerns, escalate issues, and provide timely updates.
• Real-time troubleshooting of issues that arise during manufacturing.
• Support CDMO manufacturing operator training program.
• Lead manufacturing related deviation investigations and CAPAs across the network.
• Establish network business process for root cause analysis suing established methodologies.
• Support data capture of manufacturing production through excel and other data software.
• Perform comprehensive manufacturing data analysis and trending.
• Identify and support continuous improvement efforts between Cabaletta and the CDMO.
• Review of batch records and other documentation to support product release activities.
• Support drafting documentation that will be supplied to the CMO which includes but not limited to: Batch Records, Work Instructions, forms and Memos.
• Support and review CDMO documentation from draft to finalization.
• Support any pre- clinical runs which could include verification runs, pilot runs and engineering runs at the CDMO.
• Ability to work off-shift, weekends and long hours as needed.

Secondary Responsibilities:

• Collaborate closely with Process Development, Analytical Development and Quality and provide technical expertise to successful resolution of technical issues and process improvements.
• Participate in technology transfer projects to CDMOs.
• Participate in/lead risk management exercises, develop and document process FMEAs.
• Preparation for and oversight of process performance qualification (PPQ) runs. Authoring of PPQ protocol and reports.
• Authoring of relevant sections of regulatory filings and preparing responses to regulatory requests for additional information.

Required Qualifications

• Ph.D., M.S. or B.S. degree in Biology, Chemistry, Biotechnology Sciences or Engineering with a minimum 3 + years direct work experience in biologics process development, process validation, or manufacturing under cGMP processes and ICH regulations, with specific experience in cell and gene therapy products including direct work experience in biologics process development, process validation, or manufacturing under cGMP processes and ICH regulations, with specific experience in cell and gene therapy products.
• Experience of using cell processing related equipment, such as CliniMACS Prodigy, Sepax C-Pro, LOVO cell processing system, and Xuri bioreactor.
• Familiarity with Lean and Six Sigma methodologies.
• Strong understanding and application of Lean manufacturing principles.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.  
• Experience of process validation lifecycle approach and risk assessments using a variety of tools, e.g., FMEA.
• Highly organized and efficient, strong team orientation and passion for continuous self-development.
• Ability to manage and coordinate parallel tasks across multiple projects, prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Experience contributing to preparation of documents for regulatory review, including but not limited to, INDs and BLAs.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

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