Michael Leblanc Email & Phone Number

Durham, North Carolina, United States

Remote (North Carolina)

• QED, a BridgeBio CompanyAnalytical Development
• Accountable for the analytical development of drug substance and hard-gelatin oral solid doses to support clinical trials and commercial supply via management of third-party domestic and international laboratories.
• Accountable for the analytical development of lower dose tablet and capsule formulations to support clinical trials in achondroplasia.
• Accountable for management of stability programs of starting materials, intermediates, reference standards, metabolites, drug substance and several dosage forms in support of maintaining adequate shelf-lives for.
• Responsible for managing all out-of-trend and out-of-specification results with QED and third-party QA groups. Provide technical oversight to problem solving efforts and root cause analysis studies.
• Coauthored NDA module 3 for Truseltiq (infigratinib) hard-gelatin capsules which was accepted by FDA, Canada and Australia in 2021 under project Orbis. Supported submissions in other countries for similar oncology.

Remote (North Carolina)

• Retinagenix, a BridgeBio CompanyAnalytical Development
• Responsible for reviewing analytical methodology for Zuretinol acetate and related oral solution formulations.
• Inspected GMP capability of a potential testing facility for release of drug substance and release/stability of formulations.
• Worked with team to identify suitable formulation and delivery device for Phase II studies.
• Helped to develop an appropriate potential genotoxic control strategy for the oil-based formulation.

Research Triangle Park, North Carolina

• Global External Development and Supply
• Expert in technical outsourcing of early and mid-phase projects. Continuous responsibility for managing several external projects in parallel across multiple third-parties to deliver to GMP standards.
• Primary QC approver of drug substance and drug product specifications, clinical release packages and analytical sections of regulatory submissions on outsourced projects supported by the department. Key resource in.
• Responsible for the GMP testing and documentation provided by third party contractors and the data integrity of the supporting package.
• Assessed several third parties across North America for technical and quality competency as part of due diligence on-site visits. Experienced with the approval process of a new third party and the withdrawal of.
• Member of the initiative team which drove process improvements focused on accelerating the portfolio. Helped design an overarching technical agreement procedure from both an analytical technical specialist and also as.

Research Triangle Park, North Carolina

• Emerging Markets R&D
• Analytical Project Leader for two fixed-dose combination (FDC) drug products of marketed medicines. Performed/coordinated method development, validation, stability program design, formulation support, batch release.
• Responsible for identifying suitable drug substance vendors to supply generic API to our projects at several internal and external sites. Acted as a resource for coordinating quality audits, placing orders, importing.
• Designed a specific release process for commercial API being procured by our group, as at the time the SOPs did not provide sufficient guidance for this activity. The process was agreed with the management team and QA.
• Played a key role in definitively identifying data falsification at an outside contractor performing stability work for one of these projects.
• Assisted QA with authoring Quality/Technical Agreements with API vendors in support of API procurement. Designed a product requirements specification (PRS) document template to compliment the Quality Agreement which.

Research Triangle Park, North Carolina

• Pharmaceutical Development
• Accountable for developing, validating, and authoring analytical methods for achiral/chiral purity determination of synthetic route intermediates and drug substance designated for clinical or non-clinical studies under.
• Extensive experience with hands-on generation and review of GMP data and issuing batch release documentation
• Acted as the department’s Quality leader by designing and operating a Level 1 audit program, becoming the department change control and risk management champion, participating on SOP authoring and revision teams and.
• Organized and led a multidisciplinary team tasked with transferring the analytical methods of a late phase project from the R&D team to the GMS group via a “one team” approach
• Analytical API project team leader on several projects ranging from candidate selection through Phase 3