Storm Biotechnology was founded in 2008 as a bio-pharmaceutical consulting/ contracting firm. Storm Lefelar's experience starting his career on the processing floor (in the late 1980’s) and making it to the board room (in the 2000s) gave him a great understanding of the many ways he can deliver value to Storm Biotechnology clients.
During
Storm Biotechnology was founded in 2008 as a bio-pharmaceutical consulting/ contracting firm. Storm Lefelar's experience starting his career on the processing floor (in the late 1980’s) and making it to the board room (in the 2000s) gave him a great understanding of the many ways he can deliver value to Storm Biotechnology clients.
During his journey to Storm Biotechnology many contracting firms would utilize his expertise to help them with personnel and process flows in new clean room design. Other clients would solicit Storm Lefelar to help them solve issues on their process floor. His many years working in clean rooms as an operator, supervisor, and manager gives him a unique understanding of the challenges you and your team may be facing.
Having spent time in both the US and the EU and witnessing many different solutions to common operational challenges provides Storm Lefelar with the ability to bring customized solutions to your organization.
What separates me is this hands-on experience, that I will gown and get right into your production area to help solve issues. I can prepare your facility and train your team to be ready for an FDA audit. I will help your engineering team change a pump on your WFI system. I can run the autoclave validation and provide all the documentation for you. If you want strategic planning o how to get your drug to market or your filling lines qualified to 2000 vial batches, I can help you with that too!
Click this link to Storm Biotechnology's YouTube channel to see what I love about consulting!
Hydro BioTechnology was founded in 2016 as a cGMP water manufacturing facility based in Fort Lauderdale, Florida. Hydro BioTechnology produced cell culture water (that met the USP monograph for WFI), HPLC water and water for pharmaceutical purposes.
At the time Storm Lefelar was running HydroBioTechnology (part/full time) he accepted a p
Hydro BioTechnology was founded in 2016 as a cGMP water manufacturing facility based in Fort Lauderdale, Florida. Hydro BioTechnology produced cell culture water (that met the USP monograph for WFI), HPLC water and water for pharmaceutical purposes.
At the time Storm Lefelar was running HydroBioTechnology (part/full time) he accepted a position as VP of Biotechnology Services for a mid-sized pharmaceutical company based in South Florida. While producing and selling water from Hydro BioTechnology, supporting long standing Storm Biotechnology clients and working full time as a VP it was an extremely rewarding experience.
When the pharma company asked Storm Lefelar to to become Chief Operating Officer in 2017 he decided to close the physical plant of Hydro BioTechnology. Eventually Storm Lefelar transitioned back into full time Storm Biotechnology consulting, and kept Hydro BioTechnology as his LLC.
Part of the Hydro BioTechnology water system is currently set up at Storm Lefelar's house in Big Pine Key and is used to make ultra-pure drinking water for his wife and daughter.
Check out this Storm Biotechnology YouTube video explaining the relationship between Storm Biotechnology and Hydro BioTechnology.
Storm Lefelar's day-to-day responsibilities as Chief Operating Officer for a mid-sized pharmaceutical company based in South Florida included oversight of operational strategies and ensuring daily operations conform to all aspects of cGMP. He also ensured that operations met the demands of the sales force and helped the C-Suite team nav
Storm Lefelar's day-to-day responsibilities as Chief Operating Officer for a mid-sized pharmaceutical company based in South Florida included oversight of operational strategies and ensuring daily operations conform to all aspects of cGMP. He also ensured that operations met the demands of the sales force and helped the C-Suite team navigate the future direction of the company.
Storm Lefelar previously served as Vice President of Operations for Goodwin Biotechnology, where he led the operations team through Goodwin's two most successful years in their 17-year history. Storm Lefelar was responsible for day-to-day operations including manufacturing, materials management, facilities, engineering, quality systems and process development. At Goodwin Biotechnology Storm Lefelar managed over 60 Indirect and direct reports.
Storm Lefelar also worked as manufacturing manager for DSM Biologics and orchestrated a complete upgrade of their mechanical and cGMP compliance system to meet commercial manufacturing standards for their facility in Montreal, Canada.
At Wyeth Biopharma Storm Lefelar was a member of the tech transfer team that achieved a flawless transfer of the Enbrel process from Amgen Rhode Island to Wyeth Grand Castle, Ireland. Also at Wyeth Storm Lefelar served as point person for commissioning and start-up of their pilot plant operations (four bioreactors and all associated equipment with two supporting downstream processing suites and several vialing lines.)
At PDL Biopharma Storm Lefelar spent 7 years working in various roles in manufacturing operations, large scale process development, and engineering. When Storm Lefelar was a Lead Operator the company went for 3 years with no contamination! Storm Lefelar was promoted to Supervisor and was charged with a team of 6-15 operations staff that was responsible for all upstream operations and initial DSP steps. Storm Lefelar took over the cell banking facility from the PD group to ensure consistent cGMP operations and reduce contamination. Storm Lefelar also served as head of the safety committee for 3 years and participated in several build out projects and new facility construction design. Storm Lefelar oversaw the process and new equipment validations at PDL’s various sites in Minnesota and California.
Imclone Systems was his start in biotech in 1992 where Storm Lefelar was a manufacturing technician (one of the first 15 employees hired at the New Jersey facility that would produce Erbitux.) His duties included equipment prep, media buffer compounding and bioreactor manipulations. While there Storm Lefelar learned validation, reactor commissioning and start up activities.
Storm Lives in Big Pine Key, Florida with his wife Jennifer and daughter Carly. They enjoy spending time out on the boat fishing and exploring. Storm Lefelar is a former bicycle racer, triathlete, and marathon runner and still enjoys all these activities.
Copyright © 2023 Storm Biotechnology Web Site - All Rights Reserved.