Cmc
Current
Mar 2024 - Present
AeroLeads people directory · profile
Leslie Wolfe Email & Phone Number
CMC - Cell and Gene Therapy
at
Orca Bio
1 work email found
@generationbio.com
3 phones found area 617 and 508
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
Role
CMC - Cell and Gene Therapy
Location
Cambridge, Massachusetts, United States
Who is Leslie Wolfe? Overview
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Quick answer
Leslie Wolfe is listed as CMC - Cell and Gene Therapy at Orca Bio, based in Cambridge, Massachusetts, United States. AeroLeads shows a work email signal at generationbio.com, phone signal with area code 617, 508, and a matched LinkedIn profile for Leslie Wolfe.
Leslie Wolfe previously worked as CMC at Orca Bio and Senior Vice President - CMC at Generation Bio. Leslie Wolfe holds Ph.D., Biochemistry from Boston University.
Company email context
Email format at Orca Bio
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{first_initial}{last}@generationbio.com
86% confidence
AeroLeads found 1 current-domain work email signal for Leslie Wolfe. Compare company email patterns before reaching out.
Profile bio
About Leslie Wolfe
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.
Listed skills include Biotechnology, Drug Development, Commercialization, Drug Discovery, and 18 others.
Current workplace
Leslie Wolfe's current company
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8 roles · 35 years
Leslie Wolfe work experience
A career timeline built from the work history available for this profile.
Senior Vice President - Cmc
Nov 2020 - Dec 2023
Vice President - Cmc
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.
Jul 2018 - Nov 2020
Cell And Gene Therapy
Provides 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.
Sep 2017 - Jul 2018
Independent Consultant
Self-Employed
Jan 2017 - Aug 2017
Manufacturing Operations, Consultant, Cell And Gene Therapy
Jan 2015 - Dec 2016
Vice President, Techology Development, Cellular Therapies
1996 - 2014
~18 yrs
Instructor
Boston University School Of Medicine
1992 - 1996
~4 yrs
1 education record
Leslie Wolfe education
-
Boston University
FAQ
Frequently asked questions about Leslie Wolfe
Quick answers generated from the profile data available on this page.
What company does Leslie Wolfe work for?
Leslie Wolfe works for Orca Bio.
What is Leslie Wolfe's role at Orca Bio?
Leslie Wolfe is listed as CMC - Cell and Gene Therapy at Orca Bio.
What is Leslie Wolfe's email address?
AeroLeads has found 1 work email signal at @generationbio.com for Leslie Wolfe at Orca Bio.
What is Leslie Wolfe's phone number?
AeroLeads has found 3 phone signal(s) with area code 617, 508 for Leslie Wolfe at Orca Bio.
Where is Leslie Wolfe based?
Leslie Wolfe is based in Cambridge, Massachusetts, United States while working with Orca Bio.
What companies has Leslie Wolfe worked for?
Leslie Wolfe has worked for Orca Bio, Generation Bio, Biologics Consulting, Self-Employed, and Bluebird Bio.
How can I contact Leslie Wolfe?
You can use AeroLeads to view verified contact signals for Leslie Wolfe at Orca Bio, including work email, phone, and LinkedIn data when available.
What schools did Leslie Wolfe attend?
Leslie Wolfe holds Ph.D., Biochemistry from Boston University.
What skills is Leslie Wolfe known for?
Leslie Wolfe is listed with skills including Biotechnology, Drug Development, Commercialization, Drug Discovery, Cell Culture, Life Sciences, Immunology, and Biopharmaceuticals.
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