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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.
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ConsultantCloraActon, Ma, Us -
Senior Director, Analytical DevelopmentIpsen Aug 2022 - Nov 2024Supporting both clinical development program and commercial manufacturing. Received 3 "Bravo" awards for critical on-site activities at an overseas CDMO November 2022.
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Senior Director, Analytical DevelopmentEpizyme Sep 2016 - Aug 2022Senior 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 and CRO partners, fostered team-building, and traveled for F2F meetings in support of 100% out-sourcing. Responsible for an annual budget of about $3M. Currently supporting Phase I program (IND CMC section accepted with no observations).
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Analytical Development ConsultantSage Therapeutics Apr 2016 - Aug 2016Cambridge, Ma, UsSupport 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: stability trending. -
Associate Director, Analytical DevelopmentAriad Pharmaceuticals, Inc. Jan 2013 - Mar 2016Cambridge, Massachusetts, UsResponsible 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. Liaison with CMOs. Biopharmaceutics Classification studies. Training: Ishikawa diagrams, factorial design, and FMEA (Pharmstat), Project Management Fundamentals (Corporate Education Group), Fusion QbD software, Lifecycle Approach to Analytical Methods for Drug Products: Incorporating QbD Concepts (Compliance Online), USP Workshop on Lifecycle Approach to Validation of Analytical Procedures with Related Statistical Tools.Responsible for an annual out-sourcing budget of about $0.5M. -
Director, Analytical ServicesIrix Pharmaceuticals May 2007 - Dec 2012UsSupervise 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 on use of instrument. Method development, validation, transfer, primarily HPLC and GC methods. -
Sr. Staff ScientistIcos Feb 2005 - Apr 2007UsManager, 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. Development and implementation of GC-MS and LC-MS methods for IPCs, identification/confirmation of analytes, SIM for co-eluting analytes. -
Associate DirectorAai Pharma Jul 2001 - Jun 2004Wilmington, Nc, UsAnalytical Development•Evaluation / development / validation of methods (HPLC, GC, Dissolution) for API, excipients, dosage formulations [tablets, capsules, PLA microspheres, suspensions], extractables, leachables, cleaning, and stability samples using novel and compendial methods.•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. -
Associate Principal ScientistSchering-Plough Research Institute Oct 1996 - Jun 2001Kenilworth, New Jersey, UsAnalytical 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.•Promotion: Senior Scientist to Associate Principal Scientist, October 1998.Package Component Group – 1 year•Liaison with CROs performing analytical testing•Wrote SOP for developing methods for extractables/leachables testing•Assisted with trouble-shooting for OOS leachables results: investigated origin of unknowns via spiking and LC-MS experiments. -
Chemist, Temp Full-TimeAmerican Cyanamid Feb 1996 - Oct 1996Us•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
Michael Libby Skills
Michael Libby Education Details
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University Of Nebraska Medical CenterDna Adduction -
Penn State UniversityChemistry
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Duke UniversityChemistry
Frequently Asked Questions about Michael Libby
What company does Michael Libby work for?
Michael Libby works for Clora
What is Michael Libby's role at the current company?
Michael Libby's current role is Consultant.
What is Michael Libby's email address?
Michael Libby's email address is ml****@****yme.com
What schools did Michael Libby attend?
Michael Libby attended University Of Nebraska Medical Center, Penn State University, Duke University.
What skills is Michael Libby known for?
Michael Libby has skills like Chromatography, Lc Ms, Gas Chromatography, Sop, Organic Chemistry, Cro, R&d, Method Development, Dissolution, Quality Control, Assay Development, Gc Ms.
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