Supervisor, Manufacturing- First Shift

Alnylam Pharmaceuticals•Norton, MA

7d•$103,500 - $140,100•Onsite

About The Position

The Supervisor, Manufacturing 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, generation of GMP documentation, and successful execution of Drug Substance engineering and PPQ batches all the way through commercial production and launch. The Supervisor is responsible for hiring and managing manufacturing technicians to support the start-up activities and successful execution of manufacturing campaigns. This position is a first-shift on-site role in Norton, MA that will report to the Manufacturing Sr. Manager. The role is executed primarily on the floor inside the manufacturing suite.

Requirements

Five (5) or more years experience in a biotech/pharmaceutical GMP manufacturing role
Two (2) or more years experience leading teams in a GMP environment, coaching hourly/non-exempt staff, managing performance, and supporting shift operations
Knowledge of GMP regulations (CFR, Eudralex, ICH, etc)
In-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations.
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
Proficiency with Microsoft Office applications
Proficiency with process automation software, SAP, LIMS, electronic document management system

Nice To Haves

Preferred education background of BA/BS in science, engineering, or related discipline
Prior experience with MES/eBR execution and design strongly preferred
Ability to support shift hours including days, nights, weekends, rotating shifts, on-call coverage, or campaign-based extended hours.

Responsibilities

Lead, coach, and develop a team of technicians to ensure safe, compliant, and efficient operations.
Recruit, hire, onboard, and train new team members.
Foster a positive, safety-focused culture aligned with Alnylam's values and leadership principles.
Set clear goals and expectations, provide regular feedback, and support employee development.
Conduct routine 1:1s, performance reviews, and training assessments to drive engagement and performance.
Provide floor leadership, balancing operational priorities, project work, and team development.
Address employee relations and performance issues in partnership with Human Resources as needed.
Build a high-performing team focused on quality, continuous improvement, and operational excellence.
Support for new equipment commissioning & qualification testing, including attending Factory Acceptance Tests (FAT’s), reviewing/approving protocols as the end user subject matter expert, and assisting on-the-floor protocol execution
Creation and approval of GMP documentation, including SOP’s and batch records
Assisting with planning and directing an efficient layout of equipment and flow of materials
Assisting with design and implementation of electronic logbooks, batch records, and workflows within a new Manufacturing Execution System
Monitor process and troubleshoot upset conditions that may arise (equipment issues, opening deviations, inability to follow SOP, etc.)
Thorough understanding of GMP Standards, leading by example and escalating problems through the quality and manufacturing organization as needed
Technical process experience assessing equipment output to ensure it meets process expectations Independently assess situations and respond with appropriate sense of urgency to issues as they occur
Gain a thorough understanding of equipment operation and process automation systems
Ensure smooth operation of production activities
Evaluate production plans and proactively assess upcoming processes (including materials needed vs. current inventory, planned operator time off, conflicting priorities, etc.) to identify and resolve issues in advance
Ensure trained operators are available for all operations and determine where backup support may be needed
Review schedule for feasibility and work closely with Manufacturing Scheduler to resolve scheduling conflicts
General oversight of operation readiness
Develop continuous improvement mindset through KPI’s and best practices, eg regular Gemba Walks
Participates in KPI generation, reporting and countermeasures involving schedule adherence, right-first-time documentation, deviation reduction, training compliance, safety performance, throughput, and continuous improvement outcomes
Interfaces with MTS, Engineering, Maintenance, Automation, Supply Chain, Warehouse, QC, EHS, Validation, and Scheduling
Drives daily performance through Tier Management to ensure Safety, Quality, Delivery, Cost, and People are in line with site KPIs
Fosters Collaboration and Accountability to ensure that Action Items are owned, and resolved on time
Role model GMP compliance for team
Perform batch record reviews as needed and support team with errors or corrections to limit document revisions
Drive excellence through document reviews
Interface with Quality Assurance and other support groups to ensure operators can focus on execution
Maintain inspection-ready areas, supporting audits/regulatory inspections, and coaching technicians on inspection behaviors.
Support/lead deviation investigations, root cause analysis, CAPA execution, change controls, or audit inspection support
Accountable for EHS compliance, safe work permits, PPE, safety observations, incident escalation, and investigation support
Individual possesses a Quality by Design Mindset striving toward Right First Time Standard of Excellence
Performs real time review of documentation to ensure GMP quality and drive optimum batch turnaround time
Other duties as assigned