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Director, Sterility Assurance (Relocation Available)
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$150,000 - $217,500 a year
Full-time
- We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
- Lead the network Sterility Assurance program, including supporting manufacturing sterility investigations (example: aseptic process simulations, drug product sterility testing, and other microbial excursions).
- Strong knowledge of microbiological testing including drug product sterility, endotoxin, aseptic process simulations, and sterile manufacturing sterility investigations
- Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP, and JP monographs for microbiology
- Knowledge of Biosafety Level (BSL) requirements and use of risk assessment for the selection of appropriate microbiological practices
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