Ryan Richards Email & Phone Number

Gaithersburg, Md

Support Clinical Immunology by validating that 21 CFR Part 58 and GCLP standards are adhered to. Validate data packets and calculations, create/update an organized physical and electronic database, and provide software qualification as needed.

Rockville, Md

• Lead analyst responsible for training new hires in the QC Flow Cytometry department and setting guidelines• Responsible for ordering and maintaining lab supplies and equipment (including service and vendor contract purchase orders)• Liaison between manufacturing and QC/QA, set schedule and orders necessary materials for QC testing (as well as set the priorities)• Perform QA review for finished good inspection• Completed OOS, failure investigations, deviations, and CAPA’s.• Work with R&D for their individual projects• Write and revise SOP’s and specifications for products, maintain data/records to comply with regulatory requirements• cGMP/cGLP compliance experience (including ISO 13485 and 21 CFR 820)• Perform flow cytometry, antibody/fluorescent cells staining, tissue culture, and cell counts/viability for raw material, in-process, and final bulk products• Perform safety audits• Support technical transfer to other corporate sites

• Performed tissue experiments and assisted the principal investigator in data mining• Performed CFU-GM colony growth and counting• Performed ELISA testing

• Performed endotoxin testing, automated cell counts, BSL-3 clean room work• Routine water sampling and testing• Qualified in aseptic gowning for clean rooms and suites• Qualified in aseptic technique• Trained with client for cell therapy validations

Bachelor Of Science (Bs), Biology/Biological Sciences, General

Education record