I lead two teams within Preclinical Manufacturing and Process Development (PMPD) responsible for development and scale-up of bioreactor processes for our many development and preclinical programs and data enablement and analytics for the department. Bioreactor Scale-Up and Development provides toxicology material for preclinical and speed to clinic programs, performs scale-up and confirmation of late-stage clinical processes according to principles of quality by design, provide various research materials for company, development of viral barriers for upstream processes, process transfer and input for regulatory documents. Data Enablement and Analytics provides oversight of PMPD IT and OT systems for collection, visualization and analysis of process data, custom applications and integration, and oversight for data science efforts. Responsible for equipment specification for upstream scale-up activities including stainless steel, SIP bioreactors, single use bioreactors, and associated equipment. Provide oversight for department's current infrastructure expansion and updates, having completed three successful, on time projects, to expand production capacity to support our growing biotherapeutic pipeline.

I manage two teams within Preclinical Manufacturing and Process Development (PMPD) responsible for development and scale-up of bioreactor processes for our many development and preclinical programs and data enablement and analytics for the department. Bioreactor Scale-Up and Development provides toxicology material for preclinical and speed to clinic programs, performs scale-up and confirmation of late-stage clinical processes according to principles of quality by design, provide various research materials for company, development of viral barriers for upstream processes, process transfer and input for regulatory documents. Data Enablement and Analytics provides oversight of PMPD IT and OT systems for collection, visualization and analysis of process data, custom applications and integration, and oversight for data science efforts. Responsible for equipment specification for upstream scale-up activities including stainless steel, SIP bioreactors, single use bioreactors, and associated equipment. Provide oversight for department's infrastructure expansion and updates, having completed three successful, on time projects to expand production capacity to support our biotherapeutic pipeline.

I manage a group (currently 24 members) within Preclinical Manufacturing and Process Development (PMPD) responsible for development and scale-up of bioreactor processes for our many development and preclinical programs. Provide toxicology material for preclinical and speed to clinic programs, perform scale-up and confirmation of late-stage clinical processes according to principles of quality by design, provide various research materials for company, and development of viral barriers for upstream processes. Also involved in process transfer and input for regulatory documents. Responsible for equipment specification for upstream scale-up activities including stainless steel, SIP bioreactors, single use bioreactors, and associated equipment. Serve as key liaison for PMPD with Regeneron's Facilities Department in regards to utility systems and infrastructure.

I manage a group (currently 14 members) within Preclinical Manufacturing and Process Development (PMPD) responsible for development and scale-up of bioreactor processes for our many development and preclinical programs. Provide toxicology material for preclinical and speed to clinic programs, perform scale-up and confirmation of late-stage clinical processes according to principles of quality by design, provide various research materials for company, and development of viral barriers for upstream processes. Also involved in process transfer and input for regulatory documents. Responsible for equipment specification for upstream scale-up activities including stainless steel, SIP bioreactors, single use bioreactors, and associated equipment.PMPD Lead on infrastructure expansion project from early 2015 to mid-2016, which provided additional pilot scale and bench scale capacity for the PMPD department to meet development goals. Worked closely with Regeneron's Facilities Department, construction management company, consulting engineering firms, various trades and PMPD members to successfully design and execute project on aggressively short timelines.

Manage a group (currently 11 members) responsible for scale-up of our many development and preclinical programs. Provide toxicology material for preclinical programs, perform scale-up and confirmation of late-stage clinical processes, provide various research materials for company. Also involved in process transfer and input for regulatory documents. Responsible for spec and input on design of new equipment for Pilot bioreactor suite. Supervised the installation of new bioreactor equipment ranging from 5L to 500L, including medium delivery and CIP systems, into our state of the art facility at Regeneron. Also have experience with Single Use Bioreactors.

Manage a group of 9. Our group is responsible for scale up of bioreactor processes for various stages of development. We produce the preclinical material for tox studies as well as a number of reagents for our research groups. We work with scales ranging from 2L to 700L. I was focused on design of new bioreactor equipment for our new Pilot Bioreactor Suite located in Regeneron's new buildings from mid-2008 through 2009.

I was responsible for production of recombinant proteins and monoclonal antibodies using mammalian cell culture for both research and preclinical studies. Skilled at operating stainless steel bioreactor equipment ranging from 40L to 700L working volume. Also proficient at cell culture and operating bench top bioreactor equipment. Experience with semi-perfusion, batch and fed-batch mammalian cultures as well as fed-batch bacterial fermentation. Limited experience with purification of proteins using various chromatographic steps, SDS-PAGE, Western Blots. Managed a group of 2-5 process development associates and engineers beginning in 2003.