Experience

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  Roche diagnostic systems

  Jan 1990 - Jan 2006

  Steadily advanced through series of promotions based on outstanding performance and dedication.Contractor - Operations (2000 to 2006)Created and conducted 14 training seminars to 400 employees for corporate-wide batch record harmonization initiative and spearheaded implementation across multiple teams.Analyzed plant wide NCEs (Non Conforming Events) - trended root cause analysis Identified key areas for improvement, and executing (CAPA) corrective and preventative actions.Prepared BLA, PMA, IND regulatory submissions. Prepared for FDA auditsImprove SOP documentation, tracking validation status, facilitated process improvements by analyzing supply/demand data and computing scale-up requirements for critical oligonucleotides and enzymes used in multiple product lines. Show less Managed, mentored and trained 10 direct reports: GMP bulk manufacturing, quality control testing, batch record completion, SOP execution and designValidated new clean room facility class 100,000 for DNA production. Liaison to third party clean room manufacturing, filling and labelingOptimize product availability of quantitative standards for entire PCR product line at stock, buffer, bulk and component levels.GMP manufacturing of Development and Production bulks. Developed Quality Control specifications, In-Process and Stability Testing 3 Diagnostic product linesPrepared weekly schedule and organized resources for production, testing and filling groups to meet replenishment and new product launch schedules to meet corporate financial goals.Trained third-party contracting personnel in manufacturing, testing and documentation procedures and served as technical troubleshooting and scheduling liaison.Composed technical investigation reports and execute corrective and preventative actions Show less Proficiently served as Supply Chain Planner for entire PCR product line including finished kits, filled components, bulks, critical raw materials and contract manufacturing sites.Exercised strong planning abilities to replenish and maintain inventory levels of components.Effectively collaborated with global distribution leaders and internal groups including regulatory, quality and development.Produced comprehensive monthly and long-term master production schedule demands for operations and filling/packaging and devised third-party contractor schedule.Proactively participated in cost analysis meetings to ensure compliance with budget limitations. Show less Exhibited outstanding communication skills to steer cohesive efforts between R&D, PD, and Manufacturing teams.Planned, managed and documented all assays transferred from R&D to PD.Efficiently scheduled production of PD batches with strict adherence to regulatory requirements, and tracked status of new production batch records for bulk manufacture.Navigated production scheduling of launch batches and communicated kit availability to organization, global distribution managers and clinical study leaders. Show less Held accountability for accepting transfer, production, scale-up, testing and stability of strept-avidin HRP conjugate used in all PCR diagnostic kits.Utilized knowledge of GMP regulations to validated new clean testing laboratory, recommended critical raw material substitutions, and create/improve Production Batch Records and SOPs. Spearheaded bulk production of latex beads for drug diagnostic detection kits, executed all testing on Olympus analyzer, and evaluate data and generate trendlines. Show less

  • Project Management

    Jan 1990 - Jan 2006

  • Group Leader

    Jan 1996 - Jan 2000

  • Master Scheduler - Operations

    Jan 1994 - Jan 1996

  • Scientist - Manufacturing Support

    Jan 1992 - Jan 1994

  • Assistant Scientist

    Jan 1990 - Jan 1992
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  Hoffmann la-roche

  Sept 2006 - Nov 2008

  Project manager

  Coordinated 12 U.S. Pandemic Preparedness workshops and led activities of each cross-functional team: (Account Management (AM), Brand Team, Event Planning, Facilitation Teams and Panelists) Led pre-workshop panel member meeting training, facilitator training. Generated post-workshop feedback/areas of improvement to teams.Created, facilitated and trained all AM on new MaxIS market trend survey. Summarized market trend survey data for NAOC meetings identifying account's pandemic preparedness. Prepared widely distributed 'Pandemic Monitor' - a bi-weekly news summary capturing noteworthy world-wide clinical and preparatory activities surrounding pandemic influenza.Created 'FAQ' - a snapshot summary tool for AM and tracked/shared AM's Best Practices. Show less

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  Hoffmann-la roche, inc

  Nov 2008 - Jul 2010

  Project manager

  Medicare Rebate Program Xeloda and Cellcept; Track contracts for >350 pharmacies.Provided customer service, resolve issues/complaints, define data requirements. Collaborated with Account Managers (AMs) to enroll their Chain and Specialty Pharmacy accounts in the rebate program. Analyzed rebate data and market trend data to predict Gross-To-Net forecasting and modeling. Provided training to AMs.

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  Optic nerve research center (onrc) - clinical trials

  Feb 2012 - May 2016

  Project manager

  Project Manager: Ophthalmology requirements for multiple clinical trials for major pharmaceutical and gene therapy sponsors. Study effects of drug, gene therapy and gene splicing modifiers on anatomical and functionality of the human eye using OCT, FAF, Multi-Color imaging and Fundus PhotographyAcquired a thorough scientific understanding of Optical Coherence Tomography (OCT) image capture and analysis generated from six manufacturers, more than doubling ONRC's capability. Conducted world wide site training on OCT capture and Ophthalmology requirements of each study. Created special webcasts for FAQ, Best Practices, Troubleshooting for quality OCT image capture. Identified and instituted a variety of process improvements including standardization of specifications, documentation, and quality assurance processes. Created multiple reference tools to regulate QA/QC processes, minimize variability and standardize communications to sites.Created sponsor tailored report status, findings, safety alerts, data reconciliation. Provided training to in-house team on each new clinical trial and the associated testing specifications. Create relationships with each Sponsor and at each site with Study Coordinators and OCT Technicians to ensure quality data and clinical trial success. Show less

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  Wuxi apptec advanced therapies

  May 2016 - Feb 2020

  Senior project manager

  Senior PM at CMO for Advanced Therapy Clients developing gene-therapy, cell-therapy, red cell therapeutics from R&D to Commercialization.Projects: Manage 4 high profile clients concurrently to drive new products from concept into production. Leads internal and external cross-functional teams to manage operational activities to plan, implement, execute, control, report and close projects. Maintain alignment on CMO business goals/client goals.Budget: Responsible for 100% on time invoicing for each client, based on multiple contract terms. Average $1M-$2M/month. ~70-300 line items/client. Understand and enforce contract terms. Invoice upon deliverables. Identify and negotiate scope change and new work orders.Client Relations: Host Face to Face and weekly meetings with Gene-therapy, red-cell therapeutics, master cell bank production organizations. Identify problems/organize appropriate sub- teams to resolve issues. Enforce contracts and agreements. Facilitates documentation.Timelines: Generate and monitor client specific project timeline based on client goals, internal lead times/restraints. Provide key milestone updates and communicates schedule-impacting issues. Identifies risk and recommends. Communication: Provide consistent minutes, updates, dashboards, urgent communication to all stakeholders. Document decisions, risk register and key milestones. Escalate timeline/schedule risks for support and mitigation. Identify area of improvements – leads implementation. Show less

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  Johnson matthey

  Mar 2020 - now

  Senior project manager

  Lead global, cross-functional teams to ensure successful delivery of new product introduction and changes to JM's Generic API pipeline.

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  Wuxi advanced therapies

  May 2021 - now

  Associate director commercial managment