Specialist III, External Manufacturing

Job#: 3013174 Job Description: Specialist III - External Manufacturing (Biotech)Client:Biotechnology companyContract/Perm & duration: 12-month contract Location: TorontoThis 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 groupsSupport 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 metProcess 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 remediationClosely collaborate with production planner and provide inputs on ExP specific constraintCommunicate 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 activitiesAppropriately manage ExP related contracts (MSA, SOWs, QAAs) Update metrics (KPIs) and reports as neededAssist with cross-functional requests and projects as neededSupport the Annual SCM Budget process for all categories by aligning functional needs with ExP pricing and timingKey Qualifications:Minimum of a Bachelor’s degree in business, scientific discipline or related field is requiredExperience with third-party management is preferred.Demonstrated experience with procurement and logistics support preferredHighly 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 changeWorks well with others on both an individual level and in team environmentExcellent written and verbal communication skillsExperience with GxP guidelines/documentation and general GMP experience is an assetDemonstrated application of quality and efficiency improvement methods such as LEAN, Six Sigma is preferredExperience in working with electronic systems. ERP, Smartsheet, Oracle, Coupa, Microsoft Office ProgramsAbility 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 Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.