OverviewThe 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.
Key Responsibilities- Day-to-Day People Management
- 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.
- Commercial Train Start-Up
- 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
- Independent Resolution of Complex Problems
- 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
- Quality and Compliance
- 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
Qualifications- Preferred education background of BA/BS in science, engineering, or related discipline
- 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
- 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.
The pay range below 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 days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
U.S. Pay Range
$103,500-$140,100 USD
