Christopher Levell

Experience

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  Amgen

  Nov 2011 - May 2017

  Packaging product in a cGMP environment in compliance with FDA guidelines Operating auto labelers for various drug products (vials, syringes, sure-clicks)Performing product take outs in compliance per our SOP Inspecting drug product and verifying material and batch numbers Storing finished drug product in compliance per our sop in its correct CRT Receiving & Delivery Clerk for AMGEN (OCE Business Svc) Duties include but not limited to: Receives perishable material and distributes throughout the Amgen campus.Responsible for proper handling and processing of hazardous materials.Delivers incoming materials to campus locations in a timely manner.Box truck driverMaterial Coordinator 2 for AMGEN Distribution Duties include but not limited to:NHU process- the picking up and sorting of samples according to their CRT and distributing them accordingly.Performs GMP day to day Duties in a safe compliant manner.Provides expertise and guidance to distribution staff on a Standard Operating Procedures and Standard Work.Updates and maintains team metrics.Performing cycle counts Works closely with key stakeholders and customers to complete/ improve day to day activitiesWith coaching and guidance, performs the following activities:Applies problem solving tools to drive meaningful root causesIdentifies effective corrective actions for addressing issues.Receives general direction and work may be guided by team requirements or department objectivesProactively prioritizes workload based on metrics and department needs. Responsible for maintaining all product Bin to Bin moves in a GMP environment. Responsible for printing and picking daily orders by batch number per SOP, GMP and FDA guidelines and shipping them out in a timely manner.Responsible for daily product complaints processWorked heavily in CRT environment: 2-8 and -30 freezers Responsible for picking and packing T-vec shipments Mostrar menos  NHU process- the picking up and sorting of samples according to their CRT and distributing them accordingly. Performs GMP day to day Duties in a safe compliant manner. Provides expertise and guidance to distribution staff on a Standard Operating Procedures and Standard Work. Updates and maintains team metrics. Performing cycle counts  Works closely with key stakeholders and customers to complete/ improve day to day activitiesWith coaching and guidance, performs the following activities: Applies problem solving tools to drive meaningful root causes Identifies effective corrective actions for addressing issues.Receives general direction and work may be guided by team requirements or department objectives Proactively prioritizes workload based on metrics and department needs.  Responsible for maintaining all product Bin to Bin moves in a GMP environment.  Responsible for printing and picking daily orders by batch number per SOP, GMP and FDA guidelines and shipping them out in a timely manner. Responsible for daily product complaints process Worked heavily in CRT environment: 2-8 and -30 freezers  Responsible for picking and packing T-vec shipments Mostrar menos

  • Manufacturing Associate 1

    Jan 2015 - May 2017

  • Materials Coordinator 2

    Nov 2011 - Jan 2014
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  NantKwest

  Feb 2017 - Jan 2018

  Inventory Control Specialist

  Inventory Control SpecialistReceive incoming shipments non-GMP/GMP materials and equipment following established proceduresProcessing and placing materials in quarantine (consumables , media, antibodies ,etc.)Working with QA to make sure they have everything they need to release material for MFG and QC groupsContacting vendors to obtain certificates to release materialsWorking with master scheduler to ensure we have materials per processMonitor Kanban area to ensure optimum replenishmentCycle counting, and communicating inventory discrepanciesDispensing materials in compliance per SOP to Mfg. and QC groupsWorking and assisting in clean room environmentManage packaging and shipment of final drug productKeep warehouse clean and audit readyAssist head of department manage day to day assignments and monitor completion of required activities Mostrar menos

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  Kite Pharma

  Jan 2018 - Jun 2018

  Material cordinator 2

  Material Coordinator II Cryo -Packaging Final Drug ProductKitting per manufacturing scheduleReceiving LN2 Dewar’s per or SOPResponsible for preparing LN2 Dewar’s for shipmentWorking with Oracle to ship and dispense materials to MFG teamAssist other groups of the Material Management when coverage is neededCycle count and report discrepanciesMaintain our work areas and stay audit readyRecharging Cryoport Ln2 Dewar’sShipping and receiving Commercial/Clinical APH Shipper kit Mostrar menos

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  Atara Biotherapeutics

  Jun 2018 - Jan 2022

  Oversee Clinical Distribution, Sample management, cGMP receiving, Vial Transfers, Dispensing, and Bulk Drug product shipments. Work with a group to start up a cGMP multi product facility. Which include A, B, C class materials including, Cell Bank, Frozen Bulk, Finished Goods, Virus, Leukopaks, and Final Dose Formulated intermediates. Cryo tank mapping to ensure product segregation. Initiate Scars as needed. Execute material qualification protocols. Secondary label testing for commercial label. Commercial packaging testing. Month end purchase order reconciliation with finance. Preform (UAT) User acceptance testing. Create locations in ERP as needed. Plan cycle counts in ERP. Perform Batch record review for clinical distribution. Ensure all activities that must be performed are on calendar, and up to date. Attend multiple WCT (work center teams) meetings to communicate issues. Work close with logistics to ensure on time shipments. Update inventory status in ERP (Block/Un-block). Oversee all employees within the Warehouse Operations department including 9 warehouse associates Set team Goals/Reviews. Approve timecards, and time off request. Mostrar menos Inventory management of cGMP materials and supplies, includes raw materials receiving and inspection Part of a group working to start up a GMP facility Billing and invoicing of purchase orders, materials and purchased supplies.Transactions involveA,B,C class materials including: but not limited to Master Cell bank,Frozen bulk,Finished goods and VirusLead employees of cGMP warehouse op’s teamTook part in cGMP Warehouse Risk assessment to help establish process flow.Help develop OJT’s and other trainings ( ERP work instructions) .Shipping and Cryo packaging Final drug product via D365 ERP system.Prepare warehouse facility for audits,assuring that all documents, area of work, product and personal abide to all FDA regulation Mostrar menos

  • Supervisor Warehouse Operations and distribution

    Oct 2020 - Jan 2022

  • Sr Warehouse Associate

    Jun 2018 - Oct 2020
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  FUJIFILM Diosynth Biotechnologies

  Jan 2022 - now

  • Warehouse And Distribution Manager

    Jun 2022 - now

  • Supervisor Warehouse Operations and Distribution

    Jan 2022 - now