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I have experience in the biotechnology business with a focus on CMC activities including process development, analytical development, manufacturing and regulatory compliance with cell and gene therapy products.My most recent job was at Generation Bio:● Manage and built a team of scientists engaged in the manufacturing of a novel DNA genetherapy product for non-clinical/animal studies.● Oversees the project work of 30+ scientists in upstream and downstream processdevelopment to build research scale and scale-up procedures using both cell and non-cell based (enzymatic synthesis) processes.● Manage the Analytical Development team to establish testing programs for both the drugsubstance and drug product using lipid nanoparticle delivery systems.● Supervising efforts of external vendors working on drug substance and drug productformulations for non-clinical and clinical phases.● Responsible for the compliance of these efforts.● Completed FDA submission for the CMC sections of an INTERACT (pre-preIND) review.
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CmcOrca Bio Mar 2024 - PresentMenlo Park, Ca, Us -
Senior Vice President - CmcGeneration Bio Nov 2020 - Dec 2023Cambridge, Massachusetts, Us -
Vice President - CmcGeneration Bio Jul 2018 - Nov 2020Cambridge, Massachusetts, UsManage and built a team of scientists engaged in the manufacturing of a novel DNA genetherapy product for non-clinical/animal studies.Oversees the project work of 30+ scientists in upstream and downstream processdevelopment to build research scale and scale-up procedures using both cell and non-cell based (enzymatic synthesis) processes.Manage the Analytical Development team to establish testing programs for both the drugsubstance and drug product using lipid nanoparticle delivery systems.Supervising efforts of external vendors working on drug substance and drug productformulations for non-clinical and clinical phases.Responsible for the compliance of these efforts.Completed FDA submission for the CMC sections of an INTERACT (pre-preIND) review.
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Cell And Gene TherapyBiologics Consulting Sep 2017 - Jul 2018Alexandria, Virginia, UsProvides guidance in the CMC development, GMP manufacturing and regulatory compliance for cell and gene therapies.Participates with clients to progress product and process definition, biomaterials sourcing and control, clinical-scale process development and commercial deployment.Determines strategy for distribution and packaging design of in-coming patient materials and out-going final drug product.Provides guidance on quality testing profiles and strategies for development of analytical assays.Prepares regulatory documentation for all development phases of a drug substance and drug product, including pre-IND, IND/CTA submissions and BLA/MAA filings. -
Independent ConsultantSelf-Employed Jan 2017 - Aug 2017
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Manufacturing Operations, Consultant, Cell And Gene TherapyBluebird Bio Jan 2015 - Dec 2016Somerville, Massachusetts, Us -
Vice President, Techology Development, Cellular TherapiesGenzyme - A Sanofi Company 1996 - 2014Paris, France, Fr -
InstructorBoston University School Of Medicine 1992 - 1996
Leslie Wolfe Skills
Leslie Wolfe Education Details
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Boston UniversityBiochemistry
Frequently Asked Questions about Leslie Wolfe
What company does Leslie Wolfe work for?
Leslie Wolfe works for Orca Bio
What is Leslie Wolfe's role at the current company?
Leslie Wolfe's current role is CMC - Cell and Gene Therapy.
What is Leslie Wolfe's email address?
Leslie Wolfe's email address is lw****@****bio.com
What is Leslie Wolfe's direct phone number?
Leslie Wolfe's direct phone number is +161725*****
What schools did Leslie Wolfe attend?
Leslie Wolfe attended Boston University.
What skills is Leslie Wolfe known for?
Leslie Wolfe has skills like Biotechnology, Drug Development, Commercialization, Drug Discovery, Cell Culture, Life Sciences, Immunology, Biopharmaceuticals, Biochemistry, Molecular Biology, Technology Transfer, Validation.
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