Experience

Arcus Biosciences

• United States
• Biotechnology
• 300 - 400 Employee

• Senior Vice President, Pharmaceutical Development and Manufacturing

  • Jul 2022 - Present

  Responsible for process development, manufacturing, and commercialization of Arcus product portfolio of small and large molecules.

• Vice President - Antibody Development and Manufacturing

  • Feb 2021 - Jul 2022

  Responsible for development, manufacturing, and commercialization of antibodies used in combination therapies for cancer treatment.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Executive Director - Special Assignment: Operations Lead Amgen-Lilly COVID Antibody Collaboration

  • Sep 2020 - Feb 2021

  Accountable for all Operations aspects for Project Light Speed to manufacture etesivimab which recently received EUA for use in combination with bamlanivimab for COVID-19 treatment. Scope included due diligence, services agreement, tech transfer, quality, supply chain and DS and DP manufacturing.

• Executive Director, Process Development - Drug Substance Technologies and Engineering

  • Mar 2018 - Sep 2020

  Accountable for process engineering organization ensuring successful implementation of multi-modality drug substance processes in the GMP environment from first-in-human clinical to commercial manufacturing across Amgen's internal and external manufacturing network. Responsibilities span technology transfer, process validation, process monitoring, regulatory submission authoring and inspection support, continued process optimization for yield and robustness, sophisticated digital capabilities… Show more Accountable for process engineering organization ensuring successful implementation of multi-modality drug substance processes in the GMP environment from first-in-human clinical to commercial manufacturing across Amgen's internal and external manufacturing network. Responsibilities span technology transfer, process validation, process monitoring, regulatory submission authoring and inspection support, continued process optimization for yield and robustness, sophisticated digital capabilities including advanced process/plant modeling and design, new next-gen facility startup, and ensuring technology readiness for manufacturing implementation.

• Executive Director, Process Development - Secondary Packaging Engineering

  • Apr 2016 - Mar 2018

  Responsible for process development team developing, characterizing, qualifying, and implementing secondary packaging for various final drug product configurations including vials, syringes, and advanced combination products; developing advanced process and equipment technologies for secondary packaging for Amgen’s manufacturing network; and global artwork and labeling management.

• Director, Global Operations Planning and CMC Lifecycle Management

  • Oct 2013 - Apr 2016

  IMLYGIC Global Operations Leader (GOL) Led the Product Delivery Team responsible for all CMC aspects of IMLYGIC commercialization leading to commercial approval and launch. IMLYGIC is the first oncolytic viral therapy approved in the United States, European Union, and Australia. Operations Lead on the Global Product Team that developed robust cross-functional product strategy incorporating clinical development, regulatory, commercial, and operations considerations. Drove all CMC… Show more IMLYGIC Global Operations Leader (GOL) Led the Product Delivery Team responsible for all CMC aspects of IMLYGIC commercialization leading to commercial approval and launch. IMLYGIC is the first oncolytic viral therapy approved in the United States, European Union, and Australia. Operations Lead on the Global Product Team that developed robust cross-functional product strategy incorporating clinical development, regulatory, commercial, and operations considerations. Drove all CMC activities, including process and product development, manufacturing, quality, regulatory, and supply chain to ensure reliable uninterrupted supply of IMLYGIC to patients.

• Director, Process Development - Colorado Process Engineering

  • May 2011 - Oct 2013

  Director of Amgen Colorado Process Engineering Led a department of about 40 scientists, engineers, and operations staff. Served as the primary interface between Process Development and Manufacturing/Quality organizations. Provided process technical support for commercial and clinical drug substance manufacturing operations for mammalian cell culture and microbial process for Prolia/Xgeva, Epogen, Nplate, and trebananib, including technology transfer/scale-up, process validation… Show more Director of Amgen Colorado Process Engineering Led a department of about 40 scientists, engineers, and operations staff. Served as the primary interface between Process Development and Manufacturing/Quality organizations. Provided process technical support for commercial and clinical drug substance manufacturing operations for mammalian cell culture and microbial process for Prolia/Xgeva, Epogen, Nplate, and trebananib, including technology transfer/scale-up, process validation, non-conformance resolution, and change controls. Managed pilot plant operations supporting process characterization and technology transfer activities for process scale-up (e.g., centrifugation, filtration, viral inactivation, UFDF). Managed global cleaning characterization group charged with developing standardized, science-based approaches for equipment cleaning across Amgen's manufacturing network.

• Principal Engineer, Process Development

  • Oct 2006 - May 2011

  Process Team Leader for trebananib (AMG 386) Led the cross-functional team responsible for characterization, scale-up, and technology transfer of the drug substance manufacturing process into Amgen Colorado's LakeCentre large-scale manufacturing facility Successfully scaled up process (high cell density E. coli-based inclusion body process followed by 20,000L refold) for a challenging molecule resulting in successful comparability exercise and INDa submission Implemented a real-time… Show more Process Team Leader for trebananib (AMG 386) Led the cross-functional team responsible for characterization, scale-up, and technology transfer of the drug substance manufacturing process into Amgen Colorado's LakeCentre large-scale manufacturing facility Successfully scaled up process (high cell density E. coli-based inclusion body process followed by 20,000L refold) for a challenging molecule resulting in successful comparability exercise and INDa submission Implemented a real-time Process Analytical Technology-based chromatography pooling method that replaced laborious fractionation-based pooling to optimize purity and yield Developed, qualified, and characterized process using unique linked unit operation small scale models coupled with optimal experimental designs that were necessitated by unique nature of product and process and resulted in robust design space definition Process Team Leader for Kineret Led the team responsible for continued commercial manufacturing process support Conducted remedial process characterization to support revalidation of key process steps that changed post-licensure Mined legacy process characterization and manufacturing data to identify opportunities for process yield increase within the parameters of the approved BLA



FUJIFILM Diosynth Biotechnologies

• United Kingdom
• Biotechnology Research
• 700 & Above Employee

• Staff Scientist - Process Development

  • Sep 2000 - Sep 2006

  Led the development and/or transfer of over 15 cell culture (CHO, NS0, Sf-21, etc.) and microbial (E. coli, P. pastoris, etc.) processes for clinical to commercial GMP production of biotherapeutic molecules. Led the development and/or transfer of over 15 cell culture (CHO, NS0, Sf-21, etc.) and microbial (E. coli, P. pastoris, etc.) processes for clinical to commercial GMP production of biotherapeutic molecules.



National Renewable Energy Laboratory

• United States
• Research Services
• 700 & Above Employee

• Post-doctoral Researcher

  • Sep 1998 - Sep 2000

  Performed experimental research to support the US Department of Energy’s biomass-to-ethanol program while developing mathematical models for cellulase enzyme production using fungal fermentations. Performed experimental research to support the US Department of Energy’s biomass-to-ethanol program while developing mathematical models for cellulase enzyme production using fungal fermentations.