Joseph Charles Email and Phone Number

CMC Manufacturing Lead for CareFusion Infection Prevention Clinical Trial Supplies.o Responsible for all aspects of GMP Clinical Manufacturing for the ChloraPrep® Lifecycle Management franchise (Drug / Device Combination Product) as well as a number of R&D Clinical Studies for New Product Development in the CareFusion Infection Prevention Business Unit.o Co-authored a number of supporting regulatory documents including INDs for the on-time delivery of Clinical Trial Supplies to the clinic. Served as a resource and expert in GMP processes and drug product delivery. o Analytical support activities including Drug Product stability program management.

External Product Management - Manage external contracts for the formulation, analytical Drug Product and Drug Substance development of specified clinical & pre-clinical assets. Evaluate, assess, select and actively manage CMO, CRO, Lab Services and Supplies vendors for all GMP CMC work. o Internal Technical Late Phase Product Development expert – consulted for regulatory and general product development or strategic advice, assisting colleagues in developing solutions to complex technical problems and investigation of unexpected results.

Provide technical and project management leadership in order to deliver late-phase projects through development to GMS / commercial supply, ensuring the quality of that product through Post-Launch Project Handover to Commercial Supply. The role exists from Commit to Medicine Development / Proof of Concept through to file, launch and Commercial Handover ensuring that the appropriate structure, systems and controls are utilized to manage the scope, time, cost, risk, quality and resource elements for each project.o Constructed detailed Phase 3 project management plans for a clinical asset (i.e. co-ordination activities; risk management; iPLAN; FACT; etc).o Developed Commercial image and Product Image Decision Documents for a pre-Phase 3 asset and proposed a novel strategy to properly blind a comparator product injection vs our Phase 3 AFC tablet product.

CMC, Physical Product Delivery (PPD) team and Pharmaceutical Development project leader for a number of significant productso Led the CMC team consisting of chemical, pharmaceutical & physical properties development as well as Global Manufacturing and CMC regulatory functions for a new NDA submission of an internationally marketed Ophthalmic Ointment for Herpes Simplex Keratitis. Participated in the FDA pre-NDA meeting, successfully proposing and enacting novel submission strategies to the FDA Ophthalmology review group..o Led the Physical Product Delivery Team and the product development Analytical development for the Pediatric Powder for Oral Suspension (PfOS) of a late stage (post NDA / MAA file) oncology drug. Co-authored the CMC section of the Pediatric Investigation Plan (PIP) which was approved by the EMA’s PDCO in 1Q-2011 as well as represented GSK in the PDCO approval meeting. Delivered this Pediatric PfOS to the clinic while overcoming significant taste, physical stability & mouth-feel hurdles.o Co-authored a number of regulatory and scientific documents including IND, IMPD, NDA, MAA, Pediatric Investigation Plans (PIP), patent applications, scientific journal articles and white papers. Served as a resource and expert in drug product delivery. o Served as an iSTAB (International Stability Management) Steering Team member.o Analytical support activities including DP & API stability program management, dissolution methods development & testing for GSK’s lead MEK inhibitor asset (Oral AFC Tablet) as well as the now internationally marketed drug, Votrient (oral AFC Tablet).o Awarded the GSK Exceptional Science stock award for successfully leading the development of a robust discriminating dissolution method for a complex and unusual solvate

Physical Product Delivery (PPD) team and Pharm Dev Analytical & Project Leader for a number of Phase 1 & 2 drug products. Stability Study Manager for several injectable & oral drug products as well as drug substance for multiple GSK compounds.o Took over and refocused a behind-schedule program, managing the process to bring product development & manufacturing up to speed while effecting a major formulation change from solution to a lyophilized powder for infusion and successfully meeting every clinical timeline.o Led the Pharmaceutical Development project for CMO manufacturing activities of a sterile Lyophilized (powder for infusion) drug product at an external research partner in Halle / Westphalia, Germany. Served as the Pharmaceutical Development Liaison in the successful three-way technical agreement, negotiations and product transfer between GSK, UK & EU partner companies to manufacture & release a sterile lyophilized powder for infusion through externalization.o Awarded the GSK Exceptional Science stock award for successfully troubleshooting a major lyophilized product quality issue at CMO in Germany and instituting CAPAs (corrective and preventative actions).o iSTAB Stability Pharm Dev lead trainer for all Analytical Chemists and Team Leaders at GSK-PA sites.o Led or participated in multiple successful regulatory inspections including pre-PAI, PAI, WWRC, EH&S and QA Site Audits as well as internalPPD Steering Team review presentations, Design Intent – Early Risk Management (DI-ERM) reviews and Drug Product Formulation Forum (FF) reviews to CMC upper management for multiple projects.

Development & validation of robust analytical methods for investigation of drug substance as well as oral / injectable dosage forms or antibiotics, oncology and supportive care. Generate & interpret data to support release & stability testing of formulated drug product for clinical & regulatory filings including in-licensed compounds from USA & EU partners.o Successfully participated in all analytical activities including stability program management, regulatory documentation and analytical methods transfer to commercial manufacturing site for the world’s first oral topoisomerase inhibitor for the treatment of NSCLC, Topotecan Hydrochloride (oral Hycamtin), now currently marketed in the EU & USA.

Implementation of GC / LC / MS methods for compounds not amenable to routine techniques. Acquire and analyze biological samples from Duke University and the Duke University Medical Center as well as various companies in the Research Triangle Park, NC and other universities and corporations throughout the country.

Doctoral research in development, optimization and the application of a bonded phase DNA aptamer in capillary electrochromatography of isomeric oligopeptideso Invented a DNA based oligonucleotide gel stationary phase for biomolecule separations.

Guided and evaluated undergraduate Seniors in advanced analytical instrumental, analysis and preparative ACS certified laboratory techniques.Responsible for reinforcing concepts and principles as well as administering, evaluation and grading of class assignments.Guided and evaluated undergraduate Freshman and Sophomores in their understanding of Accelerated & Advanced General chemistry instrumental, material and laboratory techniques.