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A results-oriented strategic executive, Mary is experienced in leading efforts focused on effective drug supply within the pharmaceutical industry, with particular focus on business change and improvement. Mary’s strong technical, business, and regulatory acumen enables her leadership of initiatives and multifunctional teams to solve complex problems encountered in drug development and commercial supply. With more than 30 years in pharmaceuticals, Mary’s experience and leadership spans broadly across drug development and tech transfer (active ingredient and drug product), internal and contract (CDMO) manufacturing, global supply, regulatory, program/project management, business assessment, risk management, and cost management needs and issues. She is equipped to lead and/or support diverse and complex efforts in Pharmaceuticals and other industries with similar challenges.Mary can support your needs in: Drug Supply Strategy (drug substance and/or drug product), Program/Project Management, Tech Transfer, Process Validation, API development and manufacture, CDMO Operations, Lean Sigma initiatives, and Change Management.
Maryfcooke Consulting
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Principal ConsultantMaryfcooke Consulting Nov 2021 - PresentProviding consulting services to the pharmaceutical industry. Mary can support your needs in: Drug Supply Strategy (drug substance and/or drug product), Program/Project Management, Tech Transfer, Process Validation, API development and manufacture, CDMO Operations, Lean Sigma initiatives, and Change Management.
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Director, Program ManagementCorden Pharma Colorado Inc. Sep 2015 - Sep 2021Boulder, CoInitiated and led newly formed API CDMO Program Management department, focused on successfully meeting customer expectations and achieving business initiatives through effective project/program management and scale up expertise. Managerial responsibilities included project management, technical transfer, process engineering, and capital project management. Mary drove initiatives to develop systems, tools, and templates to effectively support project management, customer communications, project financial evaluation and control, technical transfer/scale up, and risk evaluation/mitigation across the product lifecycle in a CDMO environment. During Mary’s leadership of the PMO department, the organization’s project portfolio grew by more than 4X and included six products that successfully progressed from clinical phases supply through process validation/filing/commercial approval.
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Senior Director Of OperationsSiegfried Usa, Llc Jan 2014 - Sep 2015Pennsville, NjManagerial responsibility for API and drug product intermediate production, planning, process engineering development, scale up, and DEA compliance. Led lean sigma-based initiatives focused on improving manufacturing and process efficiency in a manufacturing-constrained expanding API business.
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Director, Technical Operations / Operations LeaderEndo Pharmaceuticals May 2009 - Jun 2013Led cross functional teams to ensure and enhance supply of commercialized brand and generic drug products via CMO’s. Activities included identification, selection, contract negotiation and qualification of CMO’s; technical transfer of products to CMO sites; product launch planning; identification and implementation of programs to maximize chance of uninterrupted on-quality/on-time drug product supply from CMO’s and API suppliers. Responsible for ensuring all aspects of drug supply, including technical, supply chain logistics, quality, and regulatory. -
Director Of Strategic ProjectsJohnson Matthey / Pharm Matls 2005 - 2008Led multifunctional projects in strategic growth areas of North American API business, including development/commercialization of new products, significant reductions of cost of manufacture, supply chain coordination and global sourcing strategy, etc.
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Director Of Operations / Pharm MatlsJohnson Matthey 1998 - 2005Managed all aspects of North America API commercial operations, including manufacturing, technical operations, facility maintenance and capital improvements, supply chain, EHS, and DEA compliance for API business. -
Director Of Operations / Chem Process R&DThe Dupont Merck Pharmaceutical Company 1991 - 1998Established new Operations team and led qualification of new pilot plant. Integrated pilot plant activities, physical sciences/thermochemistry, and facility maintenance/improvements to support development and scale up of new active pharmaceutical ingredients for clinical trials.
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Various Technical And Managerial Positions Of Increasing ResponsibilityDupont Pharmaceuticals 1985 - 1991
Mary Cooke Skills
Mary Cooke Education Details
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Chemical Engineering -
Lean Six Sigma Certification
Frequently Asked Questions about Mary Cooke
What company does Mary Cooke work for?
Mary Cooke works for Maryfcooke Consulting
What is Mary Cooke's role at the current company?
Mary Cooke's current role is Principal Consultant at MaryFCooke Consulting.
What is Mary Cooke's email address?
Mary Cooke's email address is ba****@****hoo.com
What is Mary Cooke's direct phone number?
Mary Cooke's direct phone number is +163147*****
What schools did Mary Cooke attend?
Mary Cooke attended Bucknell University, Villanova University.
What skills is Mary Cooke known for?
Mary Cooke has skills like Cross Functional Team Leadership, R&d, Pharmaceutical Industry, Drug Development, Pharmaceutics, Chemistry, Technology Transfer, Supply Chain Management, Project Management, Strategy, Validation, Leadership.
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Mary Cooke
Minneapolis, Mn4gmail.com, thethorburngroup.com, fjorgedigital.com, fjorgedigital.com1 (612) 2XXXXXXX
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