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Rob Roman

Head Of Quality Systems at ArsenalBio

Rob Roman has extensive work experience in the pharmaceutical industry. Rob started their career as a Manufacturing Technician at Genentech in 1999 and progressed through various roles such as Process Coordinator and Supervisor in Logistics, Planning, and Scheduling. In 2005, they became a Senior Supervisor in the Large Scale Cell Culture department, managing a team of Bioprocess Technicians.

In 2006, Rob became a Manager in e.coli Cell Culture production and was responsible for managing a department of manufacturing personnel. Rob then moved on to become a Senior Manager in CHO Cell Culture production, overseeing a department of 50 manufacturing personnel and a $10 million budget.

In 2010, Rob took on a global leadership role as the Global Lead for Biologics Drug Substance Training at Genentech. Rob led and developed an international network of training and learning personnel across multiple manufacturing sites. Rob also served on executive leadership teams and was responsible for developing training programs and systems.

In 2013, Rob joined Roche Pharmaceuticals as the Director of Purification Manufacturing, leading a department supporting the Penzberg Downstream Processing Unit and the Global Biologics Production Network. After that, they became the Director of Operational Quality and Compliance, where they built and led a department focused on operational quality.

Rob returned to Genentech in 2017 and held multiple roles, including Head of Quality Systems & Compliance for Hillsboro Individualized Therapies and Head of Compliance for Hillsboro Technical Operations. In these roles, they were involved in the production start-up activities and quality approach for cell and gene therapies.

Most recently, Rob joined ArsenalBio in 2021 as the Head of Quality Systems. Rob is responsible for establishing quality systems, compliance, and documentation standards to support technical operations. Rob oversees both GxP and non-GxP systems and plays a crucial role in ensuring regulatory compliance.

Overall, Rob Roman's work experience demonstrates their expertise in quality systems, compliance, and operational management in the pharmaceutical industry.

Rob Roman received their Bachelor's Degree in Ecology and Systematic Biology from California Polytechnic State University-San Luis Obispo, which they attended from 1993 to 1998. In 2002 and 2003, they obtained a Certificate in Project and Program Management from the University of California, Santa Cruz. Rob also completed a PMP (Project Management Professional) certification from PMI - Project Management Institute in 2005. Additionally, they have an additional certification in the Genentech Quality Certification Program from Genentech / Roche PT Quality. The dates and specifics of this certification are not provided.

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Timeline

  • Head Of Quality Systems

    September, 2021 - present

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