Experience

益方生物 InventisBio
• China
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• AD Clinical Suppy Chain

  • Jun 2021 - Present

Grifols
• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Clinical Trial Materials Manager

  • Mar 2020 - Sep 2021

Catalent Pharma Solutions
• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Sr. Clinical Supplies Manager

  • Oct 2016 - Mar 2020

PPD
• United States
• Research Services
• 700 & Above Employee
• Global Clinical Supplies Project Manager

  • Aug 2015 - Oct 2016
• Clinical Trial Materials Project Manager

  • Apr 2012 - Aug 2015

  Supply clinical trial investigator sites with investigational product and ancillary supplies for US and Global trials. Forecast the amount of IP and ancillary supplies for the trial. Develop clinical labeling with Regulatory input. Develop distribution strategies with either internal capabilities or through external CTM vendor. Develop Pharmacy Manual. Develop user requirements for Interactive Web System that will manage site inventory and subject status. Ensure sites are adequately supplied with IP throughout the trial. Complete Drug accountability at study closeout. Project management throughout each phase of the trial with cross functional teams. At any time, manage supplies for four or more trials in various study phases.

• Operations Specialist

  • Nov 2006 - Apr 2012

  In support of clinical and toxicological production processes- In preparation for the clinical or toxicological campaign, determine material needs based on planned number of lots. Maintain raw materials through external requisitions. For clinical production, generate CCR to implement new raw materials, including materials clearance, creating a new SAP number, purchase specification, CQAI, and testing procedures. Track receipt, inspection, and release of materials. Generate CCR to create Bill of Material in SAP. Execute SAP production Process Orders. Involved with shipping and receiving bulks to contract filling facility, both through physical management and within SAP. Create training matrices for clinical productionDepartment Designate Trainer - Train new employees and notify all employees of latest training requirements. Generate the reports that notify to managers weekly of employee training status. Schedule site mandated training in department monthly meetings. Complete biennial curricula review and revise training curricula. Liaison for department as it relates to questions about training from Performance Development.Department Archivist - Implement a records management system of archiving research notebooks and reports. Create system to organize internal documents that are not encompassed in site GMP systems. Work with vendors to convert all research notebooks to PDF. Once scanned, all research notebooks are archived in long-term off-site storage.



Talecris Biotherapeutics, Inc.

• United States
• Biotechnology
• 200 - 300 Employee

• Gamunex Storeroom Coordinator

  • Jan 2005 - Nov 2006

  Maintain SAP for production. Manage the requisition, delivery, and organization of all production supplies. Maintain SAP for production. Manage the requisition, delivery, and organization of all production supplies.



Bayer Pharmaceuticals

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Laboratory Coordinator

  • Jan 2001 - Jan 2005

  Responsible for the day-to-day operation of the Technology laboratory. Support research scientists. Calibrate and troubleshoot analytical equipment according to SOPs: pH meters, conductivity meters, turbidimeter, spectrophotometer. Ensure GMP compliance. Chair weekly safety audit. Maintain inventory through BBP and SAP. Coordinate outside contracts: repairs (EMAC) and calibrations. Assist with projects, on an as needed basis. Responsible for the day-to-day operation of the Technology laboratory. Support research scientists. Calibrate and troubleshoot analytical equipment according to SOPs: pH meters, conductivity meters, turbidimeter, spectrophotometer. Ensure GMP compliance. Chair weekly safety audit. Maintain inventory through BBP and SAP. Coordinate outside contracts: repairs (EMAC) and calibrations. Assist with projects, on an as needed basis.