Scientist II, Quality Control

Role: Scientist II, QC Analytical, responsible for performing GMP-compliant QC testing of raw materials, in-process, water, and drug product samples in a cGMP environment, primarily at the Framingham site. Responsibilities include establishing and maintaining QC procedures, reviewing data, managing laboratory systems and equipment, generating method qualification reports, and overseeing sample handling and storage. The role involves supporting audits, regulatory inspections, and troubleshooting analytical methods and equipment. The scientist may oversee junior staff, provide training, and assist with lab investigations such as OOS and OOT deviations, ensuring GMP compliance. Qualifications: BA or BS in analytical chemistry or related science; 5+ years experience in GMP/GLP labs with knowledge of analytical techniques; proficiency in MS Office, good organizational and communication skills; ability to work independently and collaboratively. Preferred skills include experience with USP/EP testing, lab validation, and technical studies with external vendors. High-Value: Focused on biologics or oncolytic immunotherapies, emphasizing GMP, quality control, and regulatory compliance within a biopharma manufacturing setting. Location: On-site in Framingham, MA, with a 5-day workweek; travel expectations not specified.