Frank Anuszewski

Role
Sr Engineer, Tech Transfer at Merck
Location
Philadelphia, PA, US
LinkedIn followers
500 followers

About Frank Anuszewski

I am a chemical engineer at Merck & Co. Inc. in the West Point Technical Services…

Experience

  1. Sr Engineer, Tech Transfer

    Merck

    Jun 2018 — Present

    In this role I am supporting technical transfer of novel polysaccharide vaccine intermediates from lab/pilot scale to a newly constructed commercial facility. My primary responsibility is process validation / process performance qualification-Developed GMP change control strategy for startup project, and trained new authors on Merck\'s change management processes / systems -Developed Process Performance Qualification (PPQ) strategy for bulk manufacture of polysaccharides isolates from multiple serotypes of a single species of microorganism using a single manufacturing platform -PPQ strategy was designed to generate a robust data set to ensure that the process performed as intended while allowing operational flexibility necessary to supply the subject vaccine\'s clinical program -Coordinated completion of all prerequisite experiments and documents supporting PPQ with the process development team -Authored cGMP documents governing PPQ including protocols, change control, and technical summary / communication documents -Developing process data management strategy for my department and implementing / championing digital tools that are new to Merck

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Frank Anuszewski — Sr Engineer, Tech Transfer at Merck in Philadelphia, PA, US | Unifers