Marc Charles Email & Phone Number

Chicago, Illinois, Us

-Leading role in high level cross functional teams providing drug product supply chainstrategies established to support complex clinical trial protocol needs.- Develop and manage international supply chain for open label, single and double blindedglobal trials including direct oversite of manufacturing and release of a variety of packageand label configurations.- Develop and manage drug product and clinical trial supply chain budgets, develop &execute cost saving strategies and ensure project timelines are met for on time delivery ofmaterial to clinical sites.- Coordinate drug return, accountability, and destruction process.- CMC technical documentation responsibilities include IND and IMPD submissions.- Other technical documentation includes addressing 120-day agency follow up questions,drug product deficiency questions from agencies globally, draft, review/update andapprove new SOPs, drug substance, drug product, packaging and labeling master andexecuted batch records, product specifications and more.- Interphase directly with the Quality team to release batches of key raw materials, drugsubstance and drug product, CMO/CRO deviations, OOT and OOS investigations, manageproduct complaints are a few examples of my technical responsibilities supporting CMC.- Establish vendors (CDA/MSA), audit and transfer manufacturing/analytical processes toCRO/CMO vendors.- Support strategic drug formulation development to meet FDA commitment of having apediatric formulation.- Successfully managed drug product commercial validation process and supported drugsubstance commercial process validation of the companies lead phase III compound.

Philadelphia, Pa, Us

Provide a dynamic range of services regarding clinical supply chain materials global distribution,packaging and labeling.- Forecast clinical supply demand and manage clinical supply inventory throughout the clinicaltrial globally.- Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollmentrates, inventory usage, and trends.- Utilize simulation tools and supply chain expertise to determine packaging campaign anddistribution strategies.- Work with IXRS vendors in creation of system specification for supply algorithms andmanages drug supply portion of IXRS development for clinical trials.- Manage clinical supply depot set-up and monitor depot inventory throughout study.- Manage clinical drug for a wide range of study types, including packaging design andcontingency planning.- Build drug projections, distribution strategy, packaging schedules, as well asmanaging/monitoring depot and site inventory levels.- Act as client advocate, assisting with study set-up with CRO.- Work in an unblinded capacity with secure, confidential study information.- Participate in and lead high level cross-functional teams.- Manage the project budget (protocol and program level).- Participate in CMC meeting to help manage expectations and ensure clear communication.- Supports comparator procurement strategies.- Requests manual drug orders as needed.- Manage/monitor/procure ancillary and comparator supplies inventories.- Provide final drug accountability reports to Clinical group.- Coordinate drug return, accountability, and destruction process.- Manage IMP across multiple clinical trials when necessary.

Foster City, Ca, Us

Delivered support for the outsourced manufacturing of Gilead’s API products to third party vendors.- Coordinated and monitored manufacturing of key raw materials and drug substance to support Gilead’s global API supply chain for phase I, II and III studies.- Managed two potent (4A & 4B Safebridge) Hepatitis B Cure API phase II projects.- Supported a key late stage III API through the commercial validation process.- Lead author on a variety of technical documentation such as API, raw material and purchasing specifications, contract manufacturing manuals and CDA/MSA/MLSA.- Part of cGMP audit teams for key raw material and API vendors.- Established contract and managed a 1.5 million-dollar FTE contract with CRO to support the synthesis of compounds and process route development.- Managed contract, budget and projects with > 10 external FTE’s at CRO to support Gilead’ssolid-state group.- Generated and maintained budgets and timelines for projects.- Provided strategic supply chain development.- Provided leadership with internal and external cross functional teams to maximize collaboration between key stakeholders and vendors to ensure seamless team and project continuity and information sharing.

North Chicago, Illinois, Us

Managed a team devoted to validation work to ensure analytical method processes meet current standards for impending patent renewals, regulatory filings and for national and international compliance. Tasked to make sound decisions about scheduling, allocation of resources, and managing priorities of a heavy work load comprised of a diverse product portfolio. Provided analytical troubleshooting support, supported OOS investigations and trained personnel on new methods. Developed, qualified and transferred methods for faster more reliable testing of products. Draft, review and approve a variety of controlled documents.

Abbott Park, Illinois, Us

Hand selected to be a part of a new billion dollar division (Established Drug Products) leading the work-stream based in Basel, Switzerland as the subject matter expert on all analytical aspects of our product portfolio. Project-managed technical knowledge transfers of test methods to 3rd party laboratories and Abbott sites internationally. Managed outsourced work to third party vendors. Delivered decision-making support for transfer of manufacturing to lower-cost countries. Gap-assessed method validations, answered international- specific technical Deficiency Questions, and updated methodology to current standards to ensure continuous acceptability worldwide. Authored sections for international regulatory filings, method validation protocols, knowledge transfer plans and protocols to expand into emerging markets.

Abbott Park, Illinois, Us

Sought out assignment and resolved higher-level international challenges to Abbott’s bottom line during 6-month term at Abbott's Latin America Technical Center in Buenos Aires, Argentina. Directed status meetings with team and management. Conducted GC, HPLC, and dissolution analysis for validations, knowledge transfers, and manufacturing troubleshooting. Enabled manufacturing cost-savings via transfer of validation methodology of products to Abbott’s Mexican manufacturing sire from Solvay / The Netherlands.

Abbott Park, Illinois, Us

Delivered multi-dimensional support to one of Abbott’s top profit-generators Synthroid. Hands-on analyst and knowledge transfer SME in laboratory, manufacturing, and material supplier operations. Synthroid Product subject matter expert for all things analytical on the CMC team. Hands on Pilot Plant product development and experience and manufacturing scale up support. Partnered in establishing analytical laboratory methods materials and standards for Argentina plant to produce, package, and distribute this product in Latin America. Teamed in product reformulation, scale-up studies and repackaging of Synthroid for Zone 4B manufacturing environments. Enabled both cost and time-savings in development of faster, more robust test methods using HPLC/UPLC analysis. Managed stability chambers, drafted stability protocols based on customer or product requirements. Acquired samples at appropriate time points for testing, ran appropriate HPLC/UPLC and other required experiments and reported results.

Certificate In Pmp, Project Management

Bachelor Of Science (B.S.), Science