Staff Scientist
Silver Spring, Md, Us
Division of Biological Standards and Quality Control/OCBQ/CBER/FDAManaged production, calibration, and inventory of CBER toxin and antitoxin standards. Worked with other agencies and WHO in harmonization of standards and reference preparations. Performed review on microbiological aspects of BLA supplements and write memos of recommendation.Managed the Division’s product lot release testing plans in accordance with testing plan requirements. Performed lot release testing to facilitate lot release process, approval of licensure and supplements. Developed and optimized testing methods; Refined and expanded existing SOPs. Conducted investigations for deviations and NCMs.Reviewed and processed manufacturer’s lot release protocols in compliance with CFR 610.9 (General Safety), CFR 610.12 (Sterility), CFR 610.13 (Endotoxin), CFR 610.14 (Potency, Identity), and CFR 610.30 (Mycoplasma). Managed and performed qualification, preventive maintenance and calibration of equipment, and qualification of reagents used in testing. Managed and performed final container filling operation, lyophilization, Nitrogen backfill procedure, and ampule sealing in an ISO 17025 Clean-room class-7 environment. Managed and performed ISO 17025 Clean-room class-7 environmental monitoring.