Salubrent, a CDMO specializing in comprehensive analytical services to pharma and biotech customers, has announced that Steve Migyanko, a quality control veteran with over three decades of industry experience, has joined its team of pharmaceutical experts as Director of Quality.
Mr. Migyanko has specialized in Quality Control for more than thirty years, including twenty years of progressive management and senior operational experience with large and small molecule sterile injectable products. He has comprehensive exposure to global regulatory environments with significant regulatory inspection experience as well as experience with inspection of contract laboratories for GMP compliance.
Throughout his 27-year career working for companies such as PPD, Kashiv BioSciences, Olon Ricerca BioSciences and Oakwood Laboratories, among others, Mr. Migyanko has held a variety of key Quality and Regulatory positions. He has been a key contributor to investigation and reliability initiatives with knowledge of current industry validation strategies. He also performed validation testing for a successful USP submission. He has managed process optimization and control, in-process quality assurance, lab practices and documentation in sterile and non-sterile solid oral formulation operations.
Mr. Migyanko has implemented Quality Management Systems like Change Control, Deviation, Market Complaints, OOS / OOT and stability programs while also ensuring their effectiveness. Rounding out his considerable skill he performed the CMC implementation for filing as well as Critical Responses for observations from Agency, writing of and review of the drug substance and drug sections for submission of BLAs, NDAs and ANDAs including stability tables, Justification of Specifications, Method Validation and Analytical Procedures.
“With his broad knowledge of manufacturing, technical transfer, cGMP, validation, automation and control, Steve will be a tremendous asset to ensuring Salubrent’s growth and success as we launch our analytical services business and future sterile fill & finish operations,” said Salubrent CEO Terry Novak. “His compliance work in relation to FDA, ISO, QSR and a myriad of other requirements brings unmatched experience in our ability to serve our pharma and biotech customers’ needs.”
Mr. Migyanko is a Boston University graduate of Chemistry and Biology.