Company Description Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.
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.
Qualifications
- 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 Additional Information This Requirement is for a Financial Client. If you are a good match please reach me on 732-320-9166