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Experienced Biopharmaceutical Executive with over a decade of years of experience of increasing levels of responsibility in Clinical Operations, Supply Chain, Validation, Manufacturing and Quality. Possesses a strong background in management, project management, compliance, supply and demand planning, aseptic filling, distribution, cold chain, lean manufacturing, and finance, and in multi-national management settings. Strong background in management, project management, compliance, supply/ demand planning, aseptic filling, distribution, cold chain, lean manufacturing, and finance. Multi-national management experience.

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• Leadership skills: Multinational management experience that led multidisciplinary teams through commercialization lifecycle events. Managed groups of over 100 staff members. 

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• Clinical Supply Chain and commercial launch of therapeutics: Operations launch team leader for accountable for clinical supply chain activities for over thirty-five clinical programs from FIH clinical trials through Phase III registrational trials. 

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• Global Operations Strategic Planning

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• Develop and implement strategic sourcing strategies to reduce risk and cost: Managed over $100 million of clinical inventory including bulk, finished goods, and cell banks. Implemented lean manufacturing concepts and practices which increased efficiency of clinical operations. 

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• cGMP Quality/Compliance: Head of plant quality for two commercial manufacturing facilities and one clinical manufacturing facility. Led team through several successful regulatory approvals.  Activities included preparation, validation, lot release, and inspection readiness. 

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• Process improvement initiatives in MFG operations and quality including lean MFG: Introduced lean manufacturing concepts in a clinical manufacturing facility and a distribution center resulting in reduced costs and improved throughput. 

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• Operational readiness and start-up of Biopharmaceutical facilities: Led quality and compliance activities during startup of two manufacturing facilities. 

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• Procurement, demand, and supply planning: Managed over $100 million of raw materials, comparator drugs, and clinical/commercial inventory.  Set up sourcing strategies and created partnerships with vendors. 

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• Tech Transfer: Led multidisciplinary teams in the successful tech transfer of product from site to site.

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• Ability to interpret and apply regulatory requirements into current manufacturing process and procedures: Established the first cleaning validation protocols and requirements for multi-product biotech manufacturing facility.