Specialist - Data Assets

4 days ago


Toronto, Canada Apex Systems Full time

Specialist III - External Manufacturing (Biotech) Biotechnology company Contract/Perm & duration: 12-month contract Our biotech client is seeking an External Manufacturing & Services, Specialist III to support their External Partners & Procurement activities. The External Manufacturing & Services Specialist III, is responsible for managing the operational relationship with External Partners including Analytical Laboratories, Contract Manufacturing Organizations, and Medical Device Organizations (ExPs), and working cross functionally within the internal organization to support the manufacturing services and activities being performed or to be performed at the ExPs. Director External Manufacturing & Procurement, this position will have accountability for all operational activities (including the creation of Requisitions / Purchase Orders), owning the operational relationship with assigned ExPs, facilitating and driving discussions cross-functionally with ExPs to remediate quality or manufacturing constraints, and collaborating internally across Raw Materials Supply, Manufacturing, Quality Assurance, Project Management, CMC and GMP functions at our client. In addition, the External Manufacturing & Services, Specialist III, will collaborate with internal stakeholders to identify/track/measure KPIs and Goals & Objectives with ExPs, and own the Minutes and Action Item list with ExPs resulting from Operational and Joint Steering Team meetings. Support defining the standards for ExPs forecasts, management, manufacturing planning, and data collection in collaboration with functional groups Support in ensuring the ExP performance aligned with mutually agreed upon KPIs and Goals & Objectives. Maintain high level of communication with both local and company-wide research, development, manufacturing and CMC functions to ensure their ExP dependent needs are being met Responsible for overall ExP performance including budget and timing adherence. Together with internal stakeholders (such as Quality Assurance, Manufacturing, Legal, etc.) Lead steering cross-functional operational meetings with assigned ExP(s) to drive improvements in ExP collaboration, quality, and performance. Act as escalation contact for performance remediation Support Accounts Payable team with invoice reconciliation and actively participate in process improvement activities Assist with cross-functional requests and projects as needed Minimum of a Bachelor’s degree in business, scientific discipline or related field is required Highly functional in a fast-paced dynamic company with ability to prioritize issues under differing pressures and shifting timelines. Ability to provide exceptional service to internal customers with a sense of urgency. Experience with GxP guidelines/documentation and general GMP experience is an asset Demonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma is preferred ERP, Smartsheet, Oracle, Coupa, Microsoft Office Programs



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