Experience

BioFactura, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director Manufacturing Operations

  • Nov 2018 - Present



Canon U.S. Life Sciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Manager Manufacturing

  • Apr 2011 - Aug 2018

  Directed and managed the development and implementation of commercial manufacturing operations for RUO and IVD PCR based reagents for both commercial instrument and internal medical device system sales. As Senior Manager of Assay Operations responsibilities were to build the operational organization and facility for commercial manufacturing of RUO/IVD reagents. This included all functional areas and requirements for Supply Chain Management, Production, and Quality Control including process… Show more Directed and managed the development and implementation of commercial manufacturing operations for RUO and IVD PCR based reagents for both commercial instrument and internal medical device system sales. As Senior Manager of Assay Operations responsibilities were to build the operational organization and facility for commercial manufacturing of RUO/IVD reagents. This included all functional areas and requirements for Supply Chain Management, Production, and Quality Control including process operations, equipment selection, procurement and maintenance programs documentation, validation, staffing and budgeting required for cGMP commercial manufacturing operations. Show less Directed and managed the development and implementation of commercial manufacturing operations for RUO and IVD PCR based reagents for both commercial instrument and internal medical device system sales. As Senior Manager of Assay Operations responsibilities were to build the operational organization and facility for commercial manufacturing of RUO/IVD reagents. This included all functional areas and requirements for Supply Chain Management, Production, and Quality Control including process… Show more Directed and managed the development and implementation of commercial manufacturing operations for RUO and IVD PCR based reagents for both commercial instrument and internal medical device system sales. As Senior Manager of Assay Operations responsibilities were to build the operational organization and facility for commercial manufacturing of RUO/IVD reagents. This included all functional areas and requirements for Supply Chain Management, Production, and Quality Control including process operations, equipment selection, procurement and maintenance programs documentation, validation, staffing and budgeting required for cGMP commercial manufacturing operations. Show less



Canon BioMedical

• Senior Manager Supply Chain Manufacturing and Quality Control Operations

  • Apr 2011 - Aug 2018



Intercell USA

• Head of Downstream Mfg

  • Jul 2009 - Jan 2011

  Head of Downstream Manufacturing: Managed clinical through commercial downstream manufacturing operations for vaccines using a Transdermal Patch Delivery System. As Head of Downstream Manufacturing Production Facility, responsibilities were for coordinating and managing all activities and staffing for the Downstream, Purification, Buffer Preparation, and Support cGMP manufacturing areas for the commercial manufacturing of vaccine drug candidates. Demonstrated leadership and communication… Show more Head of Downstream Manufacturing: Managed clinical through commercial downstream manufacturing operations for vaccines using a Transdermal Patch Delivery System. As Head of Downstream Manufacturing Production Facility, responsibilities were for coordinating and managing all activities and staffing for the Downstream, Purification, Buffer Preparation, and Support cGMP manufacturing areas for the commercial manufacturing of vaccine drug candidates. Demonstrated leadership and communication skills resulted in successful cGMP production and timely delivery of bulk drug substance. Show less Head of Downstream Manufacturing: Managed clinical through commercial downstream manufacturing operations for vaccines using a Transdermal Patch Delivery System. As Head of Downstream Manufacturing Production Facility, responsibilities were for coordinating and managing all activities and staffing for the Downstream, Purification, Buffer Preparation, and Support cGMP manufacturing areas for the commercial manufacturing of vaccine drug candidates. Demonstrated leadership and communication… Show more Head of Downstream Manufacturing: Managed clinical through commercial downstream manufacturing operations for vaccines using a Transdermal Patch Delivery System. As Head of Downstream Manufacturing Production Facility, responsibilities were for coordinating and managing all activities and staffing for the Downstream, Purification, Buffer Preparation, and Support cGMP manufacturing areas for the commercial manufacturing of vaccine drug candidates. Demonstrated leadership and communication skills resulted in successful cGMP production and timely delivery of bulk drug substance. Show less



MedImmune Inc

• Sourcing Manager Supply Chain Management

  • Jan 2008 - Jun 2009

  Engineering and CRO and Business Sourcing Services: Provided technical leadership, analyzed, researched, developed and negotiated for internal and external client base the direct sourcing and contracting of services and materials for engineering projects and clinical trials required for Pandemic flu project funded through U.S. Human Health Service government contract. Successfully completed RFPs and SOWs for clinical trial services generating over $30 million dollars in cost savings Engineering and CRO and Business Sourcing Services: Provided technical leadership, analyzed, researched, developed and negotiated for internal and external client base the direct sourcing and contracting of services and materials for engineering projects and clinical trials required for Pandemic flu project funded through U.S. Human Health Service government contract. Successfully completed RFPs and SOWs for clinical trial services generating over $30 million dollars in cost savings



Human Genome Sciences

• United States
• Biotechnology
• 400 - 500 Employee

• Senior Manager

  • 1994 - 2007

  Manager Human Genome Sciences Supervisor Human Genome Sciences MAIII-MAIV Human Genome Sciences Manager Human Genome Sciences Supervisor Human Genome Sciences MAIII-MAIV Human Genome Sciences



Oncologix, Inc

• Process Development Manager Drug Development Team

  • Jan 1991 - Jan 1994

  Managed process research and scale-up development of new recombinant and manufacturing for preclinical efficacy, toxicology and Phase I human clinical trials. Implemented all standard operating procedures and documentation for manufacturing, quality control, microbiology and material handling congruent with FDA cGMP guidelines. Established, coordinated and implemented the necessary procedures and documentation for sterile fill/finish and initiation of product stability studies to… Show more Managed process research and scale-up development of new recombinant and manufacturing for preclinical efficacy, toxicology and Phase I human clinical trials. Implemented all standard operating procedures and documentation for manufacturing, quality control, microbiology and material handling congruent with FDA cGMP guidelines. Established, coordinated and implemented the necessary procedures and documentation for sterile fill/finish and initiation of product stability studies to characterize the process and establish product expiration period Show less Managed process research and scale-up development of new recombinant and manufacturing for preclinical efficacy, toxicology and Phase I human clinical trials. Implemented all standard operating procedures and documentation for manufacturing, quality control, microbiology and material handling congruent with FDA cGMP guidelines. Established, coordinated and implemented the necessary procedures and documentation for sterile fill/finish and initiation of product stability studies to… Show more Managed process research and scale-up development of new recombinant and manufacturing for preclinical efficacy, toxicology and Phase I human clinical trials. Implemented all standard operating procedures and documentation for manufacturing, quality control, microbiology and material handling congruent with FDA cGMP guidelines. Established, coordinated and implemented the necessary procedures and documentation for sterile fill/finish and initiation of product stability studies to characterize the process and establish product expiration period Show less



Genex

• United States
• Advertising Services
• 1 - 100 Employee

• Research Associate

  • 1989 - 1990



CUNO, Inc

• Laboratory Technician

  • Jan 1986 - Jan 1987