Drug Product Qc Analyst
Current- Implement and validate cGMP test methods involved in the manufacturing of bluebird bio drugs.- Scientific methods include flow cytometry, gene/protein expression, cell counting, cell culture analysis, qPCR, mass spectrometry etc.- Collaborate with CxOs around the world to oversee method executions.- Author technical documents such as SOPs, validation reports, MAAs/BLAs. - Support investigations and deviations related to drug product release and stability methods.- Consistently exposed to DoE, CAPA, CMC documentation and regulatory filings and statistical data analysis.