Senior Manager, Manufacturing Operations

Alnylam Pharmaceuticals•Norton, MA

2d•$134,600 - $182,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Proficiency with process automation, PI Historian, and LIMS preferred
Prior experience with MES/eBR strongly preferred

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