Senior Manager, Manufacturing

Overview

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.

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.

Key Responsibilities

• Plans, schedules, and manages deliverables for Train 2 operational readiness and PPQ execution
• 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
• 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
• Assists with planning and directing an efficient layout of equipment and flow of materials
• Assist with design and implementation of electronic logbooks, batch records, and workflows within a new Manufacturing Execution System
• Hire and train multiple shifts to initially support operational readiness activities and then transition those shifts into supporting daily production activities
• Establishes leading KPIs maximizing manufacturing schedule adherence
• Provides coaching, feedback, and guidance for direct and indirect reports
• Provides guidance to direct and indirect reports regarding departmental goals. Ensures accountability for goal execution
• Champions a safety mindset and approach
• Maintains staff by participating in recruiting, selecting, and orienting new hires, including development and delivery of training content
• Identifies personal growth opportunities for reports, and provides guidance on development plans to achieve those opportunities
• Partners with the Continuous Improvement subject matter experts to implement lean manufacturing principles and tools. Applies these concepts to maximize efficiency and value.
• Fosters an open culture by providing support and feedback during regular Gemba walks
• Drives GMP compliance and understands when to intervene and escalate more significant issues for resolution
• Partners with Quality functions (internal QA/QC,) to ensure timely review of new and executed batch production records, SOPs, deviations, investigations, CAPAs, and may own and drive change controls as needed
• Participates in regulatory agency audits / inspections and owns associated CAPA
• Communicates routine production manufacturing status to department head and assists as necessary with process data retrieval, processing, analysis, and presentation at various meeting forums
• Provides off-shift on-call support for issues that require escalation on a rotating schedule
• Collaborate with Engineering, Facilities, EHS, Supply Chain, Quality Assurance, Quality Control, Validation, and others to support above responsibilities

Qualifications

• B.S. in scientific or engineering field preferred
• Minimum 10+ years of relevant experience hiring and building a manufacturing team and working in GMP Manufacturing/Contract Manufacturing commercial plant in the Pharmaceutical/ biotech industry with 4+ years of supervisory experience
• In-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations.
• Broad knowledge of US and international regulations and standards (FDA, EMA, ICH). Exposure to government inspections (FDA, EMEA, etc.) for new facility approval or routine surveillance required.
• Proven ability to work independently, leadership aptitude, and good people skills with the desire and ability to work in a fast-paced, start-up environment
• Strong collaboration and team-building, communication, and organizational skills required
• Experience working with third party contractors and vendors
• Hands-on experience with plant commissioning and startup, including troubleshooting and providing solutions to complex technical and logistical issues is required
• Excellent written and verbal communication skills
• Requires proficiency in MS Office applications and SAP.
• Proficiency with process automation, PI Historian, and LIMS preferred
• Prior experience with MES/eBR strongly preferred

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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