Senior Manager, Manufacturing
Alnylam PharmaceuticalsAbout the role
<p><strong>Overview</strong></p> <p>The Senior Manager, Manufacturing Operations is an integral part of the Norton Internal Manufacturing team. This role will initially be involved in the start-up of Norton’s new commercial Drug Substance manufacturing train, including support for equipment commissioning & qualification, oligonucleotide technology transfer, implementation/optimization of enterprise systems, successful execution of Drug Substance PPQ batches all the way through commercial production and launch. The successful candidate will build and manage multiple shifts for commercial GMP manufacturing in the new train. </p> <p>This position is an on-site end to end business process owner located in Norton, MA reporting to the Associate Director of Manufacturing – Lead End User.</p> <p><strong>Key Responsibilities</strong></p> <ul> <li>Plans, schedules, and manages deliverables for Train 2 operational readiness and PPQ execution</li> <li>Project lead for designing, implementing, and optimizing SAP to support commercial manufacturing, including setting meeting agenda, driving cross-functional collaboration, and developing schedule to ensure the SAP configuration is completed on time to begin production activities</li> <li>End-user subject matter expert for commissioning and qualification testing of new equipment, including protocol review and approval and support for on-the-floor execution</li> <li>Assists with planning and directing an efficient layout of equipment and flow of materials</li> <li>Assist with design and implementation of electronic logbooks, batch records, and workflows within a new Manufacturing Execution System</li> <li>Hire and train multiple shifts to initially support operational readiness activities and then transition those shifts into supporting daily production activities</li> <li>Establishes leading KPIs maximizing manufacturing schedule adherence</li> <li>Provides coaching, feedback, and guidance for direct and indirect reports</li> <li>Provides guidance to direct and indirect reports regarding departmental goals. Ensures accountability for goal execution</li> <li>Champions a safety mindset and approach</li> <li>Maintains staff by participating in recruiting, selecting, and orienting new hires, including development and delivery of training content</li> <li>Identifies personal growth opportunities for reports, and provides guidance on development plans to achieve those opportunities</li> <li>Partners with the Continuous Improvement subject matter experts to implement lean manufacturing principles and tools. Applies these concepts to maximize efficiency and value.</li> <li>Fosters an open culture by providing support and feedback during regular Gemba walks&l
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