Join Our Crew

Responsibilities Include

• The main responsibility will involve being sterile gowned in a manufacturing suite primarily acting as Cabaletta Bio’s person in plant (PIP) in a cGMP setting at a CDMO.
  • Oversight to ensure production runs in a smooth manner.
  • Troubleshooting problems that may arise during manufacturing production and communicating to CDMO manufacturing supervisor and Cabaletta technical lead (if possible) in real-time.
  • Support CDMO manufacturing operator training program.
  • Support manufacturing related deviation investigations and CAPAs.
  • Support data capture of manufacturing production through excel and other data software.
  • Identify and support continuous improvement efforts between Cabaletta and the CDMO.
  • Review of batch records and other documentation to support product release activities.
• Ability to work off-shift, weekends and long hours as needed.
  • Ability to sit or stand for long hours.
• The secondary responsibilities will involve supporting manufacturing-related tech transfer 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.
• Other responsibilities in the lab setting will also include:
  • Work as part of Cabaletta MS&T team to support process development experiments and IND enabling experiments.
  • Following Cabaletta lab MPRs, SOPs, and work instruction to allow for the successful execution of these experiments.
  • Maintaining proper documentation of such activities via an electronic lab notebook.
  • Support lab shipping and receiving investigational material/ samples.
  • Maintain laboratory material and sample inventory, support the planning of MS&T process development materials needs and coordinate purchasing with lab manager.
  • Maintain all individual training requirements in a compliant state.
  • Other Job duties as assigned by manager.

Required Qualifications

• Minimum Bachelor’s degree
• 1-2 years of experience in pharmaceutical / biotechnology or similar manufacturing cGMP.
• Excellent aseptic/sterile techniques and prior cell culture experience are required.
• Cell therapy manufacturing scale up experience is preferred.
• Experience of using cell processing related equipment, such as CliniMACS Prodigy, Sepax C-Pro, LOVO cell processing system, and Xuri bioreactor.
• Experience with handling and expanding T cells in cell culture bags or a bioreactor.
• Excellent skills in Microsoft word, Excel and some data analysis
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Self-motivated and understands flexibility in responsibilities.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

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