Manufacturing Specialist III

Specialist III - External Manufacturing (Biotech)

Client:
Biotechnology company

Contract/Perm & duration:
12-month contract

Location:
Toronto

This position will be mostly working onsite, downtown Toronto.

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. Reporting to the Sr. 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.

This is an outstanding opportunity to contribute to bringing a new class of cell-based medicines to patients. Collaboration with a highly motivated, world-class team of scientists, engineers, and other professionals, and promises an exciting and engaging work environment for a motivated, self-starting candidate.

Responsibilities:

• 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
• Process purchase requisitions, review open purchase orders, and follow up on status of placed orders as required. Experience with Coupa is preferred.
• Own the relationship with assigned ExP(s) and act as key point of contact for our client. Responsible for overall ExP performance including budget and timing adherence.
• Together with internal stakeholders (such as Quality Assurance, Manufacturing, Legal, etc.) negotiate SoWs for assigned ExP(s) and ensure alignment with overarching Agreements (MSA and QAA)
• 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
• Closely collaborate with production planner and provide inputs on ExP specific constraint
• Communicate directly with finance department regarding purchase order approval delays and resolve and communicate results to stakeholders.
• Support Accounts Payable team with invoice reconciliation and actively participate in process improvement activities
• Appropriately manage ExP related contracts (MSA, SOWs, QAAs)
• Update metrics (KPIs) and reports as needed
• Assist with cross-functional requests and projects as needed
• Support the Annual SCM Budget process for all categories by aligning functional needs with ExP pricing and timing

Key Qualifications:

• Minimum of a Bachelor's degree in business, scientific discipline or related field is required
• Experience with third-party management is preferred.
• Demonstrated experience with procurement and logistics support preferred
• Highly functional in a fast-paced dynamic company with ability to prioritize issues under differing pressures and shifting timelines. Candidate must be highly organized and proactive.
• Ability to provide exceptional service to internal customers with a sense of urgency. Experience in a matrixed environment is preferred.
• Views change or problems as an opportunity to learn and grow; adjusts easily to change
• Works well with others on both an individual level and in team environment
• Excellent written and verbal communication skills
• 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
• Experience in working with electronic systems. ERP, Smartsheet, Oracle, Coupa, Microsoft Office Programs
• Ability to analyze and resolve abstract problems independently
• Ability to, on occasion, lift up to 20kg and/or work with a partner to lift anything heavier