Consultant
mindlance2
Cambridge, MA, us
Posted May 5, 2016
- Contract
- Management
Job description
• Supports the management of Contract Manufacturing Organizations (CMOs) responsible for the production of clinical and commercial devices, dose delivery systems, and finished goods. • Supports tactical operations at CMO site(s), including performing inventory transactions, creating batch production documentation, procurement administration, forecasting materials management and change controls. • Collaborates with cross functional team members from groups including Supply Chain Quality, Label Development, Packaging Technologies, Manufacturing Sciences, Planning and Logistics. • Principal Accountabilities: • Support Clinical & Commercial Assembly, Labeling, and Packaging of devices, dose delivery systems, and finished goods. • Coordinate shipments to and from external manufacturers from and to other CMOs, and third party vendors • Track all relevant paperwork and Enterprise Resource Planning (ERP) transactions associated with shipments inside external supply chain network • Create production readiness checklists organize material order details from Clinical & Commercial planning/quality/logistics • Generate Authorization to Manufacture (AM) packets and complete batch closures in ERP • Create PO s and approve associated invoices • Compile & deliver monthly forecasts to CMOs project managers, customer account representatives, and business development contacts • Manage component inventory in conjunction with CMO • Collaborate cross-functionally to ensure closure of manufacturing deviations/non-conformances in a timely manner • Facilitate routine meetings with external contractors and CMOs • Member of a matrix team supporting manufacturing operations at a contract site. • Create budget reports and circulate on a regular basis to a defined audience. • Manage deviation cycle time in TrackWise. • Monitor and evaluate KPI metrics to measure CMO performance. • Review and comment on Manufacturing Operations Group SOPs and serves as the subject matter expert for inventory transactions in the ERP system. • Ensures all documentation required for operations is up to date and compliant for use.
• Bachelor’s Degree (Life Science, Quality, Engineering, Business Administration or a related field) • Bachelor 1-3 years of experience or Masters 0 2 years of experience in biotech/pharmaceutical industry • Organization skills, written and verbal communication skills • MS Office proficiency
This Requirement is for a Financial Client. If you are a good match please reach me on 732-320-9166
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