Description

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC will be responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties. The individual will be involved in developing, implementing, and maintaining Quality Control review processes to uphold the highest standards in internal and external laboratory activities. The role will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant internal and regulatory requirements. Our ideal candidate will have strong experience with microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring).

Requirements

Bachelor’s degree in scientific discipline; Advanced degree preferred. Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations. Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification. Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring). Experience interacting with external testing laboratories preferred. Working knowledge of GMP and ICH guidance and both US and international regulatory requirements. Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work. Strong team orientation and passion for continuous self-development. Experience in industry or in a startup industrial setting is preferred.

GMP QC Specialist, CMC

Description

Requirements

Cabaletta Bio

Pipeline