Scientist I, Quality Control

Role: QC Analytical Scientist I/II in a biopharma setting focused on cancer immunotherapy, responsible for executing GMP-compliant QC testing on raw materials, in-process, and final drug products, and maintaining QC systems. Responsibilities include establishing and revising testing procedures, reviewing data, managing laboratory operations and equipment, generating protocols and reports, handling investigations of OOS/OOT, supporting audits, and overseeing sampling, storage, and shipping of samples. The role involves training staff and collaborating across departments. Qualifications: BA/BS in analytical chemistry or related science; 5+ years experience in GMP/GLP environments; proficiency in analytical techniques, GMP documentation, and regulatory standards (USP/EP). Preferred skills include laboratory management, troubleshooting, and external/vendor interaction. HighValue: biologics manufacturing, cGMP compliance, analytical chemistry, quality systems, and regulatory support in a cell/gene therapy context. WorkSetup: on-site in Framingham with a 5-day schedule.