Experience

RMC Pharmaceutical Solutions

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President Technical Operations | Sr Consultant

  • Aug 2021 - Jan 2023

  Develop new and existing client interactions to enhance technical project efficiency and outputs. Evaluate and expand technical resources and systems to support client needs. Provide full-range CMC assistance to clients in biopharmaceutical industry. Develop new and existing client interactions to enhance technical project efficiency and outputs. Evaluate and expand technical resources and systems to support client needs. Provide full-range CMC assistance to clients in biopharmaceutical industry.



Novartis Gene Therapies

• United States
• Biotechnology Research
• 700 & Above Employee

• Sr Director, Head of Manufacturing Colorado

  • Apr 2019 - Jul 2021

  Member of Site Leadership Team. Established and lead the Manufacturing team through site start-up, enabling of manufacturing capabilities in the facility, and successful execution of Process Qualification and Commercial Manufacturing batches. • Hired and trained a highly skilled team of 130 Manufacturing staff • Provided Manufacturing oversight of project to retrofit facility, purchase process equipment, and qualification of facility and equipment • Started GMP production within… Show more Member of Site Leadership Team. Established and lead the Manufacturing team through site start-up, enabling of manufacturing capabilities in the facility, and successful execution of Process Qualification and Commercial Manufacturing batches. • Hired and trained a highly skilled team of 130 Manufacturing staff • Provided Manufacturing oversight of project to retrofit facility, purchase process equipment, and qualification of facility and equipment • Started GMP production within 10 months of site purchase • During COVID... delivered 100% success rate on 100+ batches within first year of production • Successfully increased production rate by 300% in 1st year of production Show less Member of Site Leadership Team. Established and lead the Manufacturing team through site start-up, enabling of manufacturing capabilities in the facility, and successful execution of Process Qualification and Commercial Manufacturing batches. • Hired and trained a highly skilled team of 130 Manufacturing staff • Provided Manufacturing oversight of project to retrofit facility, purchase process equipment, and qualification of facility and equipment • Started GMP production within… Show more Member of Site Leadership Team. Established and lead the Manufacturing team through site start-up, enabling of manufacturing capabilities in the facility, and successful execution of Process Qualification and Commercial Manufacturing batches. • Hired and trained a highly skilled team of 130 Manufacturing staff • Provided Manufacturing oversight of project to retrofit facility, purchase process equipment, and qualification of facility and equipment • Started GMP production within 10 months of site purchase • During COVID... delivered 100% success rate on 100+ batches within first year of production • Successfully increased production rate by 300% in 1st year of production Show less



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director MS&T

  • Dec 2017 - Mar 2019

  Member of the site leadership team. Hired a team of 220+ staff at the site, supported capital project to retrofit the facility, started-up and qualified facility, and delivered successful execution of tech transfer and process performance qualification (PPQ) batches of internal product. The experience of hiring and developing a high performing organization from scratch for an entire site was an incredibly rewarding experience and I was challenged to grow and stretch as a leader. •… Show more Member of the site leadership team. Hired a team of 220+ staff at the site, supported capital project to retrofit the facility, started-up and qualified facility, and delivered successful execution of tech transfer and process performance qualification (PPQ) batches of internal product. The experience of hiring and developing a high performing organization from scratch for an entire site was an incredibly rewarding experience and I was challenged to grow and stretch as a leader. • Technology Transfer that resulted in Process Performance Qualification Runs with 100% success rates and no failed Process Validation parameters Show less Member of the site leadership team. Hired a team of 220+ staff at the site, supported capital project to retrofit the facility, started-up and qualified facility, and delivered successful execution of tech transfer and process performance qualification (PPQ) batches of internal product. The experience of hiring and developing a high performing organization from scratch for an entire site was an incredibly rewarding experience and I was challenged to grow and stretch as a leader. •… Show more Member of the site leadership team. Hired a team of 220+ staff at the site, supported capital project to retrofit the facility, started-up and qualified facility, and delivered successful execution of tech transfer and process performance qualification (PPQ) batches of internal product. The experience of hiring and developing a high performing organization from scratch for an entire site was an incredibly rewarding experience and I was challenged to grow and stretch as a leader. • Technology Transfer that resulted in Process Performance Qualification Runs with 100% success rates and no failed Process Validation parameters Show less



MedImmune

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director MS&T

  • Mar 2016 - Dec 2017

  Established and lead MS&T group supporting facility start-up and tech transfer of internal products. Established and lead MS&T group supporting facility start-up and tech transfer of internal products.



RMC Pharmaceutical Solutions

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Consultant

  • Feb 2015 - Feb 2016

  Provided Chemistry, Manufacturing and Controls (CMC) expertise to small and virtual biotechnology companies to help them advance their programs towards commercial products. Supported Drug Substance and Drug Product projects. International client basis. The opportunity to work with small companies and earlier stage commercialization than I had previously supported, offered me a different perspective on risk taking and challenged me to develop a more entrepreneurial mindset. • Technology… Show more Provided Chemistry, Manufacturing and Controls (CMC) expertise to small and virtual biotechnology companies to help them advance their programs towards commercial products. Supported Drug Substance and Drug Product projects. International client basis. The opportunity to work with small companies and earlier stage commercialization than I had previously supported, offered me a different perspective on risk taking and challenged me to develop a more entrepreneurial mindset. • Technology Transfer lead on behalf of clients transferring to a CMO • Led planning and execution of viral clearance studies; coordinating between client's CMO and contract viral clearance lab • Feasibility evaluations for using cGMP facilities for multiple cell lines and product types Show less Provided Chemistry, Manufacturing and Controls (CMC) expertise to small and virtual biotechnology companies to help them advance their programs towards commercial products. Supported Drug Substance and Drug Product projects. International client basis. The opportunity to work with small companies and earlier stage commercialization than I had previously supported, offered me a different perspective on risk taking and challenged me to develop a more entrepreneurial mindset. • Technology… Show more Provided Chemistry, Manufacturing and Controls (CMC) expertise to small and virtual biotechnology companies to help them advance their programs towards commercial products. Supported Drug Substance and Drug Product projects. International client basis. The opportunity to work with small companies and earlier stage commercialization than I had previously supported, offered me a different perspective on risk taking and challenged me to develop a more entrepreneurial mindset. • Technology Transfer lead on behalf of clients transferring to a CMO • Led planning and execution of viral clearance studies; coordinating between client's CMO and contract viral clearance lab • Feasibility evaluations for using cGMP facilities for multiple cell lines and product types Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Manager Manufacturing

  • 2012 - 2015

  • Member of Plant Leadership operating a 160,000 square foot multi-host cGMP facility • Led team of seven technical specialists responsible for product lifecycle management of five products • Product campaigns started on target schedule, had a 100% success rate, and delivered up to 25% yield increase compared to prior campaigns • Worked to advance Operational Excellence within facility, leading to qualification of plant in Amgen’s initial stages of lean six sigma

• Process Development Facility Lead, Principal Engineer, Process Development

  • 2010 - 2012

  • Single point of contact to Plant Manager for Process Development support in multi-product/multi-host facility • Provided technical oversight and managed team of 10 Process Development staff that supported clinical and commercial production of three products. All campaigns had a 95%+ success rate, were within yield targets and dispositioned on-time • Supported multiple inspections (FDA, EMEA, ANVISA, Turkey MOH)

• Technology Transfer Lead, Principal Engineer, Process Development

  • 2009 - 2010

  • Led Technology Transfer of large-scale microbial process into a commercial multi-host facility • Drove process design decision that delivered required product throughput with reduced operational risk, leading to successful first engineering run which generated material for comparability studies two months ahead of schedule • Implemented a 5-fold process scale-up that achieved 100% success rate during production runs • Received company Operational Excellence award for successful… Show more • Led Technology Transfer of large-scale microbial process into a commercial multi-host facility • Drove process design decision that delivered required product throughput with reduced operational risk, leading to successful first engineering run which generated material for comparability studies two months ahead of schedule • Implemented a 5-fold process scale-up that achieved 100% success rate during production runs • Received company Operational Excellence award for successful refold process scale-up to an unprecedented scale

• Senior Engineer, Process Development

  • 2005 - 2009

  • Executed Technology Transfer for upstream process into commercial facility • Organized and executed process characterization of harvest steps at pilot scale • Developed equipment design requirements that resulted in equipment fit for use • Provided technical support during engineering and commercial runs • Authored Process Description section of Marketing Application

• Engineer, Process Development

  • 2002 - 2005

  • Provided commercial support for large-scale mammalian process • Evaluated impact from process excursions • Provided detailed review and approval of Manufacturing Procedures and Process Validation documents