Who is Michael Libby? Overview
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Michael Libby is listed as Consultant at Clora, based in Acton, Massachusetts, United States. AeroLeads shows a work email signal at ipsen.com and a matched LinkedIn profile for Michael Libby.
Michael Libby previously worked as Senior Director, Analytical Development at Ipsen and Senior Director, Analytical Development at Epizyme. Michael Libby holds Post-Doctoral, Xenobiotics, Dna Adduction from University Of Nebraska Medical Center.
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Email format at Clora
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{first}.{last}@ipsen.com
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Profile bio
About Michael Libby
Pharmaceutical Analytical Development Chemist for xenobiotics (small molecules) drug substance and drug product (emphasis on solid oral dosage forms) with 20+ years of experience. Extensive Leadership training to enhance team building and improve supervisory skills.Highly experienced with outsourcing, building strong partnerships with CMOs and CROs. Also led internal Analytical Development and Quality Control functions.Highly experienced with: Dissolution methods development; Chromatographic methods development; validation, transfer; developing and justifying specifications; extractables/leachables. GLP, GMP, ICH guidance. CMC/CTD authoring for IND and NDA.Received 3 "Bravo" awards November 2022 by Ipsen for critical on-site work at overseas CDMO.Received "The Big Cheese" award March 2018 by Epizyme as an outstanding contributor.Presented: "QbD HPLC Method Development and Optimization for Pharmaceutical Analysis" March 28, 2012, at the ACS National Meeting, San Diego, CA.Presented: "Case Study in QbD Drug Product Development" June 22, 2012, GoSciTech Symposium at the Governor's School for Math and Science, Hartsville, South Carolina.Presented: "QbD in Pharmaceutical Development" Nov.8, 2012, at the Francis Marion University’s Science Symposium, Florence, South Carolina.Academic: Ph.D. in Chemistry. Industry: 20+ years pharma, 1 additional year in the agricultural industry [pesticides/herbicides]. Chromatographic methods [HPLC (chiral, UV, DAD, MS, ELS, CAD, fluorescence, disso finish), and GC (chiral, FID, MS)]. USP methods. Participate in interdepartmental and interdisciplinary CMC teams, project management [GLP and GMP]. Supervised up to 15 direct reports.AAPS training: routinely attend meetings since 2004, with focus on current drug development topics, analytical testing, and leadership/teamwork courses. Attended short courses: 2000 Analytical Methods and Packaging PAC, 2007 Genotoxic Impurities, 2007 CMC Challenges and Opportunities, 2008 Understanding Specifications, 2010 ICH Q8-Q11, 2012 ICH Q3D Q11 M7.
Listed skills include Chromatography, Lc Ms, Gas Chromatography, Sop, and 24 others.
Current workplace
Michael Libby's current company
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10 roles
Michael Libby work experience
A career timeline built from the work history available for this profile.
Senior Director, Analytical Development
Ipsen
Supporting both clinical development program and commercial manufacturing. Received 3 "Bravo" awards for critical on-site activities at an overseas CDMO November 2022.
Aug 2022 - Nov 2024
Senior Director, Analytical Development
Epizyme
Senior Director, Analytical Development, March 2022 to present.Consultant SEP 2016 - NOV 2016Associate Director from DEC 2016 - JUL 2018Director AUG 2018 - FEB 2022Awarded for outstanding contributions March 2018. Responsible for all NDA-enabling analytical activities for lead program (CMC section accepted with no observations). Provided oversight of CDMO.
Sep 2016 - Aug 2022
Analytical Development Consultant
Support for Phase I/II program drug substance and drug product: phase-appropriate method transfer and validation, stability tracking/trending, co-author IND updates. Assist with development of plan for establishing GMP starting material earlier in synthesis, and improving and validating the corresponding analytical methods. Support for Phase III program.
Apr 2016 - Aug 2016
Associate Director, Analytical Development
Responsible for analytical method development, transfer, validation for drug substance and drug product. Supported commercial product [including dissolution development and validation to fulfill Japan PMDA requirements] and IND-enabling method development and validation for NCE. Dissolution media development for immediate-release solid oral dosage form..
Jan 2013 - Mar 2016
Director, Analytical Services
Supervise group of 4 managers and 8 analysts. Promoted from Assistant Director QC to Director Analytical in July 2009. CMO of small molecule API and intermediates. Responsible for data integrity, quality improvements, OOS reports, liaison internally with QA and Plant, externally with clients. Identification/confirmation of analytes by GC-MS, trained staff.
May 2007 - Dec 2012
Sr. Staff Scientist
Manager, supervisor, and analyst in Process and Analytical Chemistry. 5 direct reports. Develop methods for in-process testing for the synthesis of small molecule development candidates. Act as Study Director and perform test article characterization and stability under GLP. Perform IPCs under GMP. Participate on CMC teams, assist with preparation of INDs..
Feb 2005 - Apr 2007
Associate Director
- Analytical Development
- Evaluation / development / validation of methods (HPLC, GC, Dissolution) for API, excipients, dosage formulations [tablets, capsules, PLA microspheres, suspensions], extractables, leachables, cleaning, and stability.
- Analytical representative to multidisciplinary product-development teams.
- Release testing of APIs, excipients, and pilot and pivotal-scale batches of dosage forms.
- Project management and supervision [2 direct reports]. Support GMP / SOP / Safety compliance. Credentials in both scientific and management tracks. Trained to handle controlled substances.
- Volunteered to mentor students in UNC-W M.S. Chemistry program. Performed original research.
Jul 2001 - Jun 2004
Associate Principal Scientist
- Analytical Development:Drug Characterization Group – 4 years
- Development/validation of methods (HPLC, GC) for NCEs, API stability, excipient compatibility.
- Liaison with Chemical Development, Formulations, and Stability.
- Prepare CoAs, Standard Certification for APIs by performing and collating test data
- Assist with preparation of IRB, IND, and NDA documents.
- Project management and supervision. Support GMP / GLP / SOP compliance. AnDev Safety chairperson 2000. Performed original research.
Oct 1996 - Jun 2001
Chemist, Temp Full-Time
- Developed/evaluated/validated analytical methods (HPLC, GC) for pesticides / herbicides
- Acted as Study Monitor for GLP studies at CROs
- Experience with residue methods, SPE extraction
Feb 1996 - Oct 1996
3 education records
Michael Libby education
Post-Doctoral, Xenobiotics, Dna Adduction
University Of Nebraska Medical Center
Ph.D., Chemistry
Penn State University
B.S., Chemistry
Duke University
FAQ
Frequently asked questions about Michael Libby
Quick answers generated from the profile data available on this page.
What company does Michael Libby work for?
Michael Libby works for Clora.
What is Michael Libby's role at Clora?
Michael Libby is listed as Consultant at Clora.
What is Michael Libby's email address?
AeroLeads has found 1 work email signal at @ipsen.com for Michael Libby at Clora.
Where is Michael Libby based?
Michael Libby is based in Acton, Massachusetts, United States while working with Clora.
What companies has Michael Libby worked for?
Michael Libby has worked for Clora, Ipsen, Epizyme, Sage Therapeutics, and Ariad Pharmaceuticals, Inc..
How can I contact Michael Libby?
You can use AeroLeads to view verified contact signals for Michael Libby at Clora, including work email, phone, and LinkedIn data when available.
What schools did Michael Libby attend?
Michael Libby holds Post-Doctoral, Xenobiotics, Dna Adduction from University Of Nebraska Medical Center.
What skills is Michael Libby known for?
Michael Libby is listed with skills including Chromatography, Lc Ms, Gas Chromatography, Sop, Organic Chemistry, Cro, R&D, and Method Development.
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