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Pharma MOB Portfolio Lead

Company: Bausch Health Companies Inc.
Location: Tampa
Posted on: May 19, 2019

Job Description:

Pharma MOB Portfolio Lead Location US-FL-Tampa Job ID 11730 Category Operations Pos. Type Full Time Overview The Pharma Maintenance of Business Portfolio Lead is responsible for managing business critical projects aligned with the Tampa manufacturing site priorities. The Pharma MOB projects ensure continuity of supply, provide manufacturing process improvement, enhance product quality, and support manufacturing cost reduction. Responsibilities 1. Work with the site R&D and Operations leadership to identify and a prioritize Maintenance of Business projects in support of Tampa pharmaceutical manufacturing based on the following criteria: ? Priority 1: Non-Conformance (NC), CAPA, Compliance, Product Recall, Customer Complaints, Critical Manufacturing Issues ? Priority 2: Manufacturing Supply Chain Continuity (e.g. obsolete components) ? Priority 3: Risk Mitigation (e.g. alternative sourcing of critical components) ? Priority 4: Manufacturing Efficiency and Process Improvement, Cost Reduction (CIP). 2. Ensure project plans and timelines are in place for all projects and planned activities including a detailed project charter/scope, formal project schedule, and risk assessment. 3. Monitor and report on the overall project performance against plan to ensure MOB projects within the portfolio are completed on schedule, with the required functionality and on budget. 4. Develop project resource plans, budgets, schedules and support preparation of annual operating plan and budget. 5. Manage process to accommodate new MOB requests and make appropriate trade-offs (e.g. schedule delays) with currently active projects as needed. 6. Chair regular management reviews and updates of progress against annual project goals and deliverables and communicate changes to project priorities and timelines. 7. Develop close working relationship with site leads and R&D resources to ensure alignment and balance of MOB project resource needs with other site and R&D projects. 8. Lead individual MOB projects within the project portfolio as appropriate. 9. Ensure project documentation is completed and approved per procedures. Where necessary, generate required report writing and documentation for DHF. 10. Initiate and manage Quality Change Requests (QCRs) to completion. Scope of Position: * Function as the US Engineering representative in a matrix organization across manufacturing operations, engineering, R&D and process development teams. * An individual contributor responsible for technical support to the Maintenance of Business portfolio supporting the Tampa Manufacturing site. Qualifications * BS or MS in Mechanical Engineering, Chemical Engineering, Material Science, Chemistry, Physics, or related engineering discipline. * Minimum of 5 years engineering experience with aseptic (sterile) manufacturing and/or pharmaceutical products. * Knowledge of ISO-9000 and cGMP guidelines and best practices. * Project Management (PMP) Certification desired * Six Sigma/DOE experience, training or certification desired. * Experience in direct technical support of aseptic manufacturing. * Technical and managerial experience within a FDA regulated industry. * Ability to be successful within a matrix-reporting environment. * Ability to work across organizational boundaries and technical disciplines. * Strong leadership capabilities. Ability to influence without authority. * Excellent project management, organizational, and documentation skills * Proven track record of delivering to objectives. * Significant change management experience. * Validation and transfer of new processes and materials into manufacturing. * Strong teamwork and negotiation skills. * Excellent verbal and written communication skills. * Familiar with MS Office, MS Project, and statistical evaluation software.* BS or MS in Mechanical Engineering, Chemical Engineering, Material Science, Chemistry, Physics, or related engineering discipline. * Minimum of 5 years engineering experience with aseptic (sterile) manufacturing and/or pharmaceutical products. * Knowledge of ISO-9000 and cGMP guidelines and best practices. * Project Management (PMP) Certification desired * Six Sigma/DOE experience, training or certification desired. * Experience in direct technical support of aseptic manufacturing. * Technical and managerial experience within a FDA regulated industry. * Ability to be successful within a matrix-reporting environment. * Ability to work across organizational boundaries and technical disciplines. * Strong leadership capabilities. Ability to influence without authority. * Excellent project management, organizational, and documentation skills * Proven track record of delivering to objectives. * Significant change management experience. * Validation and transfer of new processes and materials into manufacturing. * Strong teamwork and negotiation skills. * Excellent verbal and written communication skills. * Familiar with MS Office, MS Project, and statistical evaluation software.

Keywords: Bausch Health Companies Inc., Tampa , Pharma MOB Portfolio Lead, Other , Tampa, Florida

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