Manager, Manufacturing Systems

Overview

The Manager, Manufacturing Systems is an integral part of the Internal Manufacturing team. This role is the end‑user subject matter expert for the Manufacturing Execution System (MES) and Real‑Time Modeling System (RTMS). The SME will provide input to the conceptual design, detailed design, specification, user acceptance testing, implementation, qualification, trouble‑shooting, and continuous improvement of these manufacturing systems to maximize productivity.

This position is an onsite role located in Norton, MA.

• End‑user Subject Matter Expert (SME) for the Manufacturing Execution System (MES), Real‑Time Modeling System (RTMS), and other IT capability systems (such as SAP, LIMS, Infor) that support Norton manufacturing operations, with an initial focus on implementing these systems for the buildout of Norton’s new commercial drug substance manufacturing train.
• Develop user requirements, functional requirements, and/or technical specifications for deployment of new systems in close collaboration with other stakeholders.
• Identify and ensure MES solutions are fit for purpose for manufacturing operations.
• Support system configuration, testing and qualification with a focus on manufacturing usability and cGMP compliance.
• Provide routine on‑floor support for MES during start‑up, engineering runs, validation, and routine production.
• Support batch record execution and production E  workflow issues in collaboration with Quality Assurance.
• Identify opportunities to enhance manufacturing performance through improved MES functionality, automation, and data integrity.
• Maximize capacity utilization through finite scheduling and resource loading.
• Assist in creating and revising documentation and qualifying systems in alignment with policies, procedures, and regulatory requirements (e.g., 21 CFR Part 11).
• Follow applicable change control and change management procedures to plan, assess, and implement changes.
• Execute and/or manage execution of protocols, test scripts, and change plans, as applicable.
• Remain current on new technologies, trends, and best practices that can bring innovation to manufacturing execution and information systems.
• May support and participate in audit and inspection activities, including inspection readiness.
• Provide ongoing and on‑the‑floor manufacturing operations support for MES, RTMS, and other systems as applicable.
• Support the multiyear strategic planning process for MES systems to standardize execution of batch records, reduce human error, shorten batch release, and provide real‑time data while embedding compliance directly into operations.

• B.S. in a scientific or engineering field preferred.
• Minimum of 5 years overall experience, including at least 3 years working on MES/RTMS systems in the Life Sciences industry.
• Deployment experience with MES and RTMS solutions preferred.
• Previous experience in commercial cGMP manufacturing operations desired.
• Experience developing user requirements, functional specification documents and test scripts for MES/RTMS projects.
• Demonstrate understanding of networking & system security fundamentals and knowledge of S88, S95, OPC, data historian, system interfaces, distributed control systems, etc.
• Excellent communication, interpersonal, and organizational skills with the ability to manage priorities in a fast‑paced, dynamic environment.

$ – $

The pay range reflects the full‑time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short‑term incentive award (e.g., bonus or sales incentive) and an annual long‑term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well‑being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts, and a 401(k) with a generous company match. Eligible employees enjoy paid time off, wellness…