Mike Stanley

Experience

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  Hikma Pharmaceuticals

  May 1998 - Jul 2016

  Supervisor

  Assistant Supervisor Quality Technical Operations - West-Ward Pharmaceuticals formally Baxter Healthcare Cherry Hill NJ (Sterile Injectables) Cycle development and sterilization validation of all terminal products that were introduced over a ten year span. Site SME for Autoclaves and Tunnels. participated in FDA, MHRA, and EU audits. Participated in multiple FATs for autoclaves (Italy/Fedegari)and Tunnels (Bosch, Libra/IMA). Developed and prepared Product Sterilization Process Validation Reports for Regulatory/FDA submissions. Reviewed/approved all sterilization/autoclave/tunnel/oven related investigations. Show less

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  Renaissance Lakewood, LLC

  Jul 2016 - now

  Sterility Assurance/Validation Supervisor

  Responsibilities include:Supervision of media fills, dose audits, and EMPQs.● Bulk solution and emulsion steam sterilization cycle development and validation● SIP system cycle development and validation● Dry heat API sterilization cycle development and validation● Moist heat equipment/component sterilization cycle development and validation● VHP cycle development and validation● endotoxin challenges, biological indicator (BI) challenges (in solution, indicator strips, discs, ampoules) ● FH and FO calculations● Equipment commissioning and qualification● preventative maintenance procedure development● Sterilization equipment and process requalification program development● protocol/technical report generation, execution, and review● critical batch record parameter development● knowledge of cGMPs and aseptic technique/processes● gown qualified● Microsoft Office, Visio, and Trackwise Manage the sterilization/depyrogenation related programs and procedures by revising and/or developing procedures to be compliant with FDA and other international agencies. Prepare sterilization related data and summaries for agency filings and responses. Site SME for sterilization/Depyrogenation sterilization related portions of tours with customers and agency audits. Since this is a production facility, I also manage the production/sterilization related issues that are associated with a high volume facility on a daily basis ie: investigations, CAPAs, change controls, SOPs, Show less

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  ValSource Inc.

  Jan 2024 - now

  Project Manager

  BeiGene - Autoclave, SIP, Depyro Tunnel qualification