Michael Libby Email & Phone Number

Acton, Ma, Us

Acton, Ma, Us

Supporting both clinical development program and commercial manufacturing. Received 3 "Bravo" awards for critical on-site activities at an overseas CDMO November 2022.

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 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).

Cambridge, Ma, Us

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: stability trending.

Cambridge, Massachusetts, Us

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. 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.

Us

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 on use of instrument. Method development, validation, transfer, primarily HPLC and GC methods.

Us

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. Development and implementation of GC-MS and LC-MS methods for IPCs, identification/confirmation of analytes, SIM for co-eluting analytes.

Wilmington, Nc, Us

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 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.

Kenilworth, New Jersey, Us

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.•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.

Us

•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

Post-Doctoral, Xenobiotics, Dna Adduction

Ph.D., Chemistry

B.S., Chemistry