David Ashmore Email & Phone Number

Indianapolis, Indiana, Us

• Site PM for Lilly acquisition of Nexus Pharma MFG facility in Pleasant Prairie, WI• Manage site procedure project for compliance, product transfer, submission, commercialization• Work with Quality, Global L&D, SC to build procedural master list and materials management• Built dynamic tracking excel file / Smartsheet Gantt, with metrics presented to site leadership• Work with cross functional groups on the project requirements and deadlines• Working with Supply chain and the Quality group on the materials management project, helped format and build a complex excel document with tracking for all the key action items needed for materials tracking. Including metrics and data• Establish agenda and manage daily meetings. Worked with the functional groups on assignments and the completion of action items.• Managed Workshops with Lilly Global functions to gap assess and build project workstreams

Lincolnshire, Illinois, Us

• PM for R&D pipeline, working with cross functional groups to meet critical submission dates• Utilized Hive Software / MS Project to build out project timelines / Gantt charts• Owned product timeline for discovery, formulation and analytical method development • Manufacturing requirements, registration batches, product stability, and regulatory submission• Worked with RA team for submission into various world markets, including deficiency response• Managed Nexus CMO R&D project reporting to 3rd party / DOJ (value exceeding $1 million)

Lincolnshire, Illinois, Us

• Production oversight for injectable drug manufacturing (Isolator Technology) and packaging• Compliance with 21CFR, Parts 11, 58, 210/211, and 820 • Use of Siemens EMS, QAD, BMRAM, and Master Control systems• QA SME for all EMS activities, report generation, risk assessment and event response• Draft and revisions of SOP’s, Work Instructions, Forms, and quality protocols.• Event and Deviation initiations, investigations, risk assessments, and dispositions.• AQL Inspections• CAPA review board administrator• Technical Transfers for Electronic Batch Record/Master Template creation/review process• Final batch record review process• FDA Audit backroom assistant

Basel, Baselstadt, Ch

• Downstream Purification of Zolgensma• Aseptic technique in ISO certified lab, following cGMP and cGDP practices• Assist in organizing, running and sustaining MFG operations processes• Media/buffer preparation, equipment troubleshooting• Perform controlled document revisions• Assist with engineering protocols

Abbott Park, Illinois, Us

• R&D Transfer Group, Special Project• Retrospective review of Covid diagnostic procedures, per OP/GMI/STP/SCP requirements• Facilitate communication between R&D, production, and upper management• SharePoint management, utilization of eNovator, SAP, and Maximo software

Abbott Park, Illinois, Us

Production Lead: Abbott Rapid Diagnostics Division for BinaxNOW Sars-CoV-2 tests• Lead role in an incredibly fast paced production suite• Help oversee 100+ employees in conjunction with other leads, ~25 designated to me• In process quality inspections, training, equipment troubleshooting/maintenance, scrap control• Control pace of production, communicate goal status and issues to management

Abbott Park, Illinois, Us

Worked as a MFG technician within Abbott Diagnostic Division for PRISM blood screening• GMP certified technician following strict FDA requirements• Audit staging room assistant helping facilitate audit compliance requests• ISO class 5 and ISO class 8 regulated lab manufacturing• Microparticle concentrates and bulk solutions, including protein assays• Processing supported by SAP software, use of QIMS, Maximo, and MSS• Strict schedule adherence for product production, including coordination with support groups• Pilot divisional safety strategies and contribute to 5S• Team SME for SAP, problem communication, analysis and resolutions • Function as an auditor for process orders, ensuring quality and specifications are met • Some experience with PRISM platform testing and assay analysis, LIMS systems• Help innovate continuous improvement and cost reduction within manufacturing• Facilitate training of new employees

New York, New York, Us

CQ Lab Analyst: GMP and ISO regulated lab analyst• Prepare solutions for testing, analyze, process data, perform calculations and enter results into LIMS system• Use wet chemistry techniques including colorimetry, titrimetry, and PH.• Use instrumental techniques including HPLC, GC, and UV/Vis• Perform analysis and process data according to DEA, FDA, and ICH guidelines• Documentation and data review for GSO laboratories• Work with computer systems including chromatographic data acquisition software (Empower), instrument software, excel, SAP and LIMS systems.• Part of Kanban and 5S teams, helping to make the work place more efficient.

North Chicago, Illinois, Us

Chemist 1: Industrial scale GMP and non-GMP processes• Synthesis, distillation, crystallization, and purification of API’s• Ran processes independently while adhering to proper cGMP procedures• Applied mechanical skills to modify equipment and connections to ensure processing requirements were met in a safe and effective manner• Communicated operational events/issues clearly with supervision and quality assurance• Followed up and assisted with resolutions, including investigations• Troubleshot equipment and processing conditions, provided guidance to process support, and assured effective resolutions are executed in a timely manner• Trained in SAP inventory software and Delta V equipment controls• Cross trained in separations lab; method development and impurity isolation using HPLC• Continued education through organic chemistry lecture series provided by James Stambuli, Ph.D.

Us

Polymer synthesis in 50 mL to 20 L reactors. Dilutions, working with buffers, protein/fluorescent coatings, carboxylation and amination reactions, equipment calibration. Following both GMP and non-GMP micro-particle manufacturing. Working directly with quality control to fulfill product specificationsDetailed inventory documentation (both written and electronic) Final product processing

Master Of Business Administration - Mba, Business Administration And Management, Finance

Bachelor Of Science (Bs), Chemistry

Chemistry

Associate Of Arts (Aa), Art