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about

Leo Margolf-Culhane

Owner / Principal Consultant

BioPharma Project Consulting

I started BioPharma Project Consulting, LLC to deliver value in the industry that I love while doing work that I am passionate about. Guiding teams to deliver on clear goals while also motivating greater engagement and teamwork has benefits that transcend the immediate goals of the project. For each client, I seek to maximize both project success and long term value.

 

Leo Margolf-Culhane

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Leo became interested in Biotechnology while studying Microbiology at San Francisco State University. He started his career at Genentech in South San Francisco and has enjoyed success in both technical and management positions at biotechnology companies in California and Massachusetts. Leo has worn many hats in his career. As a result he can understand the perspectives and challenges of project team members who specialize in diverse disciplines such as Process Development, Quality Control, Quality Assurance, Regulatory, Validation, Manufacturing, Engineering, Automation, Building Trades, Project Controls, and more. The ability to ask the right questions, understand the answers, and quickly translate this information into a plan for execution has been a hallmark of Leo’s success.

 

Experience

BioPharma Project Consulting - Owner, Principal Consultant

Clients:

  • Wave Life Sciences, Lexington MA

  • Molecular Templates, Austin TX

  • Takeda, Cambridge MA

  • Finch Therapeutics, Somerville, MA

  • QurAlis, Cambridge MA

Taurus Project Controls Consulting, Andover MA - Senior Principal, Planning & Scheduling Services

Organized and led interactive planning sessions and developed project plans and schedules integrated across disciplines for clinical CMC programs, facility start up, CQV, and capital projects. Supported clients in U.S. and abroad such as; Novo Nordisk, in Denmark and North Carolina, uniQure in Lexington MA, and Genocea in Cambridge MA

Shire, Lexington MA - Associate Director Investigations, Manager of Technology Transfer, Senior Project Manager

Team Leader for resolution of GMP clinical and commercial deviations, Technology Transfer team leader and project manager for multiple clinical and commercial transfers, commercial CMC team project manager

Wyeth BioPharma, Andover MA - Senior Technical Scientist

Manufacturing process technical lead and project manager for commercial contract manufacturing, process related Change Controls, Planned Deviations, Manufacturing Investigation Reports, and CAPAs

Cell Genesys, Foster City CA - Manufacturing Process Engineer

Cell culture technical lead for process scale up, technology transfer and start up

Therma Inc./Inhale Therapeutic Systems, San Carlos CA - Pipefitter

Construction and installation of high purity pipe systems

Genentech Inc., South San Francisco CA - Bioprocess Associate, Manufacturing Training Specialist, Senior Technician

Production operator, trainer and technical project manager supporting clinical and commercial mAb production

Education

San Francisco State University
BS Microbiology, 1995, Magna cum Laude