Manager – FF&P Process and Project

Manager – FF&P Process and Project

Requirements

• Honors Degree in Related Science or Engineering Preferred
• Minimum 3-5 years in Commercial Manufacturing and/or Quality
• Must possess great communication, organization skills and ability to self-manage while working multi-department team
• Good knowledge of cGMP in pharmaceuticals/biologicals
• Experience in project management, quality systems and quality risk management
• Good problem-solving skills, willingness to constantly learn new things and excellent documentation skills.

Responsibilities

• Evaluate and define project feasibility, scope, timelines and quality, safety and operational requirements to address platform needs.
• Partner with the area SMEs and functional APU and APT representatives to find efficient and achievable solutions.
• Align stakeholders and supporting functions to the initiative, required support and expectations.
• Follow Site Processes as required to get project approved and launched.
• Will lead or support projects depending on the size and scope in the capacity of an End to End (E2E) Project Leader, Manufacturing Workstream Leader, Subject Matter Expert and/or Support Resource.
• Develop and lead key Change Controls to ensure timely execution and compliance.
• Author Quality Documents including URS, Quality Plans, VMPs and applicable SOPs.
• Manage Permanent and Contingent Manufacturing Resources Assigned to Projects as required.
• Lead Lean and Continuous Improvement Initiatives with emphasis on cost saving initiatives.
• Collaborate with PMO to ensure alignment of the APU with project, portfolio, risk processes and Site Strategy.
• Coordinate the APU Steering Committee Meetings.
• Facilitate new projects, evaluation of drivers and scope, and endorsement (in-take committee).
• Manager, maintain and prioritize the APU Project Portfolio in alignment with Site Portfolio Management.
• Manage interconnection and linkages between portfolio projects and escalate risks or gaps.
• Monitoring health of APU portfolio through KPI dashboard reviews and escalate conflicts or delays.
• Risk Management SPOC – engage in process for risk assessment, evaluation and mitigation (identify and escalate risks to manufacturing process/capacity).
• Represent the FFP APU platform for relevant site wide initiatives.
• Develop, implement and support knowledge transfer within APU as part of project execution.
• Provide technical support to quality and manufacturing as per priorities within the APU including regulatory commitments, failure investigations and process improvements.
• Support troubleshooting of manufacturing equipment and processes.
• Support and Execute Validation Activities including protocols and reports within Platform.
• Author and review technical reports and protocols.
• Identify and escalate risks to manufacturing process/capacity.
• Lead with the Maintenance & Reliability team to build and maintain a robust and up to date PM plan for equipment to prevent equipment breakdowns and production delays.
• Identify and escalate opportunities for cost saving initiatives.

Preferred Qualifications

• Minimum 3-5 years’ experience managing projects in Biopharmaceutical and/or manufacturing environments
• Optional: HSE requirements (mandatory if manufacturing site)