Expert Details
Pharmaceutical Manufacturing & Packaging: Sterile Pharmaceuticals, Blow Fill Seal, Liquid Filling, Solids Filling, Facilities & Equipment
ID: 739593
, USA
Furthermore, Expert has sound knowledge of engineering, metrology, equipment commissioning and qualification, regulatory requirements (FDA, MHRA, EU, cGMP, and OSHA), design and construction of pharmaceutical facilities, and manufacturing operations (Blow-Fill-Seal, aseptic processing, liquid oral dosage forms, inhalation products, eye-drops, and topical solutions). He is skilled in business operations, deviation management, communications, and project management, and is experienced in FDA and MHRA multi-product establishment inspection process. He holds a patent for molded containers and systems for pharmaceutical containers.
Specialties: Blow-Fill-Seal, automation, budgeting, calibration, CAPA, engineering, EU, FDA, GMP, facility design, MHRA, Microsoft software, packaging, personnel, process engineering, management skills, sterility assurance, validation.
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2018 to Present | Employer: Undisclosed | Title: General Manager, Corporate Board Member | Department: |
Responsibilities:French multi-national and leader in pharmaceutical contract development and manufacturing. Specializing in unit dose manufacturing, the company produces pharmaceuticals in America, Brazil, China, and France.- Developed sterile products approved for manufacturing - Achieved approval of the site to produce sterile products - Restructured the site to operate in a 24/7 configuration, from a 5/10 configuration - Guided the facility through 3 very successful FDA audits - Expanded sterile capability at the site by 3x - Significantly improved the site’s profitability - Helped guide the company to be more global - Involved in decision to purchase a production site in China - Looked at overall corporate organizational structure |
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| Years | Employer | Title | Department |
| Years: 2009 to 2018 | Employer: Woodstock Sterile Solutions (Formerly Catalent Pharma Solutions and Cardinal Health) | Title: Chief Engineer/Interim General Manager | Department: |
Responsibilities:Leading global provider of best-in-class sterile development and manufacturing solution across a broad-range of applications.- Directed and coordinated engineering activities to ensure that cost-effective strategies were developed and implemented - Maintained full compliance to requirements of customers and regulating authorities - Oversaw the metrology department, mold shop, and engineering group - Oversaw the procurement, commissioning and qualification of new equipment - Reviewed and coordinated market opportunities with Business Development - Resolved technical issues that arose. Lead investigator for most of the critical issues including media failures, customer complaints, and process failures |
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| Years | Employer | Title | Department |
| Years: 2003 to 2009 | Employer: Woodstock Sterile Solutions (Formerly Catalent Pharma Solutions and Cardinal Health) | Title: Director of Research and Development & Director of Technical Support | Department: |
Responsibilities:Leading global provider of best-in-class sterile development and manufacturing solution across a broad-range of applications.- Directed and coordinated activities and relationships related to new business opportunities, development of existing products/processes, and implementation of new technologies - Maintained effectiveness of the Quality System by ensuring compliance with all applicable corporate and regulatory SOPs and safety guidelines and by ensuring all employees receive necessary and appropriate training for their job function - Drove revenue growth through identification and initiation of contact with new customers - Developed a process for smooth transition of products and processes from R+D into commercial operation - Presented “Embossed Labeling Options for BFS Products” at the BFS IOA USA conference and annual general meeting in 2008 |
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| Years | Employer | Title | Department |
| Years: 1992 to 2003 | Employer: Weiler Engineering, Inc. | Title: Manufacturing Manager | Department: |
Responsibilities:America's leading provider of aseptic custom packaging for pharmaceutical and healthcare applications.- Directed all aspects of BFS machine manufacturing, installation, and service for global customers and managed the supply chain for ordering required parts to build the machines - Worked closely with the engineering department to ensure on-time construction and delivery of the BFS equipment - Managed the service department to ensure on-time installation and start-up of customers’ machines: maintained machines, troubleshooting customer issues, and performing upgrades to installed machines in America, Asia, Australia, and Europe |
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