Jonathan Moddle Email & Phone Number

Morgantown, Wv

Forest, Va

Supervise 9-20 staff in the Raw Materials, Incoming Inspection and QC Support Systems groups.Plan and schedule raw material and component testing to facilitate the quality release of over 100 lots of active pharmaceutical ingredient (API), excipients, and components per month.Routinely revise and update SOPs and test methods, which have resulted in increased compliance and a savings of hundreds of lab testing hours.Instituted changes to provide greater clarity for company COAs/COCs, producing a more informative document that benefits QA product releases and RA new product submissions with the FDA.Collaborate daily with Planning, R&D, microbiology labs, and outside testing labs to ensure availability of materials for production, material qualification and transfer, and new product launches.Collaborate with Warehouse management to coordinate staging of materials for sampling and inspection. (averaging over 100 raw materials and over 37 lots of printed literature sampled, inspected, and released monthly)Schedule Analytical Method Transfers and material qualification testing to support new materials and method transfers.Created and actively maintain training matrix for the Raw materials team to assess current skill sets, serve as a reference for analyst development, and ensure a workforce with a dynamic skillset to better meet business needs.100% accuracy of monthly memos to support Annual Product reviews for FDA submission.Responsible for DEA Inventory Audits and supporting documentation submitted to the DEA.Responsible for the ordering and availability of all laboratory reagents, standards, chromatographic columns, consumables, and supplies.Active participant in weekly meetings with site leadership to firm short-term production schedules for site manufacturing.Review and approve test methods, specifications, protocols, and SOPs.Lead daily team huddles, weekly team meetings, and 1-on-1 meetings with all direct reports.

Forest, Va

Developed and implemented a labor model, including establishing standard times and work details.Site project lead for the design and implementation of an electronic controlled substance inventory management system.Wrote SQL and VBA code for a fully automated scheduling tool that runs daily to capture current lab samples, sample testing status, overall summary statistics, and automatically campaigns testing, calculates testing times, and determines current workload in terms of testing hours. This tool remains the basis for all scheduling and provides a firm foundation for resource planning in the QC lab and reduced time spent scheduling by 75%.Revised procedures for the audit of chromatographic data to allow for online audit and electronic approval, saving hundreds of hours of audit time and thousands of dollars in reduced paper consumption per year.Redesigned laboratory equipment, personnel, and work areas following 5S principles, including the removal of excess equipment and instrumentation based on usage data analysis.Performed process mapping of activities and procedures to reduce waste and increase efficiency and compliance. Trainee of a week-long Lean Lab boot camp training through McKenzie Consultants and a two-week training program from Teva’s internal Operational Excellence (OpEx) team.

Forest, Va

Leadership Experience:Team Leadership. (February to December, 2011)Regularly schedule the work of a team of chemists to meet testing requirements and timelines for Finished Product, Stability, and Validation samples within the QC Lab.Accept ownership of assigned samples and the responsibility of successfully completing sample testing within specified timeframes.Helped to spearhead a 4-month scheduling effort that helped to eliminate backlogs and reduced the number of current laboratory samples by 72%. (February to June, 2011)Participated in scheduling the work of about 40 chemists during this period.The lab met the backlog reduction goal, set by Laboratory and Executive Management. Led a Product Launch that included full lab-testing of 12 Process Validation batches and 15 Finished Product batches. (October, 2011)Scheduled the work of 16 chemists to completed testing, audit, and release of all batches within a 9-day timeframe.Successful completion allowed Executive Management to move forward with FDA-approval of the new product in order to gain market exclusivity due to the timely submission.Additional Responsibilities and Experience:Routinely review and release samples from the QC Lab.Review and audit all phases of QC analyses to ensure accuracy, quality, and compliance.Author of deviation reports, SOP updates, and product/method transfer reports using GxPharma and TrackWise software applications.Documentation experience using notebooks, worksheets, and LIMS.Performed comprehensive Finished Product, Stability, and Validation testing using HPLC, UV, NIR, FT-IR, Capillary Electrophoresis (CE), Tablet Processing Workstation robotics, and wet chemistry analytical techniques. HPLC experience includes PDA, dual detectors, and dual sequence collection on Waters, HP/Agilent, and Perkin Elmer instruments.Member, Laboratory Safety Committee (March, 2007 to Dec 2012).

QC testing and method development.· Fourteen-time “Opportunity for Improvement” Award Winner for ideas submitted to increase lab productivity, safety, and efficiency.· Method development and testing for New Product Assay, Content Uniformity and Impurities tests, as well as Cleaning Validation method development. Instrumentation included HPLC, GC, and wet chemistry methods.· Performed full-testing analysis of Raw Materials as per USP requirements.· Conducted testing of Finished Products and Stability samples.· Lead GC chemist as a result of instrument knowledge and proficiency.· Lab Safety Officer and Hazardous Waste Officer.· Member of the Method Improvement Team and Safety Steering Committee.· Maintained inventory of USP Standards, approved and maintained inventory of Qualified Secondary Standards.· Trainer for a wide variety of laboratory equipment, techniques, and methodology.

Investigated swimming pool chlorinating tablet formulas and physical properties as a part of new product development.· Detected unexpected byproducts from field trial formula. Followed up with experiments and literature search, which allowed management to quickly switch to an alternative formula.· Assisted in pilot scale productions of field trial materials.

Biophysical Chemistry Laboratory; Guided an NIH-funded project studying the tertiary structure of the 3’terminus of Flavivirus genomicRNA.· Learned and modified in-vitro transcription methods to maximize RNA oligomer product yield.· Implemented the use of DNA oligomers as transcription templates. Identified differences in the melting profiles of RNA hairpins made from “clean” DNA oligomer templates vs. endonuclease-cleaved DNA plasmid templates. Subsequent transcriptions were performed using only DNA oligomer templates.· Fit RNA melting profiles to thermodynamic parameters via base sequence, pairing rules, and Turner’s rules.· Conducted molecular modeling and predicted structures of RNA oligomers using Monte Carlo simulations.

Selected to perform toxicology studies and organic synthesis to help map the receptor site of MAO.· Synthesized and injected potential neurotoxin into C57 black mice and measured the effectspostmortem.· Determined synthesized structures via GCMS analysis.