Consultant

•         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