Paul Lobben

About Paul Lobben

Results-oriented scientist with a track record of translating strategy into execution by collaborating with individuals and teams to achieve. Extensive experience in managing operational activities, including chemical development and manufacturing, validation, and technology transfer. Cross-functional leader and subject matter expert (SME) for commercialization and CMC regulatory development. Generated content for IND, NDA, and briefing books. Characterized by strong interpersonal, and written and verbal communication skills.

Experience

1. Principal Scientist, Process R & d, Cmc

   Revolution Medicines

   Feb 2021 — Present

   As the Process Research and Development technical lead I have critical role within CMC to ensure the on-time delivery of drug substance required to support clinical timelines. My responsibilities include managing R&D activities, including synthetic route selection, process optimization, technical transfer, scale-up manufacturing and regulatory filings.Responsibilities:• Responsible for developing chemical processes for the manufacture of drug substances.• Manage technology transfer, process familiarization, and drug substance manufacturing at CDMOs.• Propose alternative chemistry for drug substance and intermediates, including route evaluation and process optimization.• Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.• Write, review, and approve study protocols, manufacturing batch records, and development and campaign reports.• Author/review the relevant CMC sections of regulatory filings.• Communicate effectively within cross functional project teams.

Education

• The Paideia School

  High School

  1984 — 1988

• The Ohio State University

  Doctor of Philosophy (Ph.D.), Organic Chemistry

  1992 — 1998

• Emory University

  Bachelor’s Degree, Chemistry

  1988 — 1992

Skills

• Lc-Ms
• Project Management
• High-Performance Liquid Chromatography (Hplc)
• Organic Synthesis
• Third Party Vendors
• Gmp
• Drug Development
• Regulatory Affairs
• Nuclear Magnetic Resonance (Nmr)
• Cross-Functional Team Leadership
• Quality by Design
• Cmc Regulatory Affairs
• Third Party Vendor Management
• Technology Transfer
• Pharmaceutical Industry
• Validation