Supervisor, Manufacturing

Alnylam Pharmaceuticals • Norton, KS

295d

About The Position

The Supervisor, Manufacturing provides direct and detailed GMP manufacturing oversight of clinical drug substance manufacturing at Alnylam's Norton manufacturing site. The Supervisor is responsible for management of Manufacturing technicians and successful execution of manufacturing campaigns. The Supervisor reports to the Manufacturing Manager. The role is executed primarily inside the manufacturing suite.

Requirements

• 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 preferred
• Previous people management experience preferred
• Knowledge of GMP regulations (CFR, Eudralex, ICH, etc.)
• Ability to work in a dynamic, cross-functional environment
• Proficiency with Microsoft Office applications
• Proficiency with process automation software, SAP, LIMS, electronic document management system
• Critical Thinking & Decision Making
• Continuous Improvement Mindset
• Ability to work shift hours

Responsibilities

• Day-to-Day People Management
• Oversight of Performance: Set clear expectations and goals, assess and identify training needs across the team to ensure understanding of operations and staying up-to-date on training status, conduct regular 1:1 meeting with team members; regular on-the-floor supervision; provide timely coaching & feedback to team; conduct bi-annual performance reviews
• Prioritization and Time Management: Manage technicians time to appropriately prioritize competing demands (on-floor operations, project work, document revisions, etc.)
• Recruitment and Onboarding: Interview and select new team members; onboard/train new team members
• Managing Team Dynamics: Prioritize, address, and resolve personnel-related issues in a timely manner; document personnel-related issues
• Talent Development: Understand individual needs and goals; support employees' development toward personal/professional goals; utilize leadership and development resources
• Leadership and Team Development: Develop and demonstrate behaviors in line with positive team culture that represent Alnylam's core values and leadership philosophy; champion a safety-focused environment
• Performance Management: Understand performance management process at Alnylam including when to escalate, engage HR, and provide increasing performance interventions or disciplinary actions as needed
• Independent Resolution of Complex Problems
• Monitor process and troubleshoot upset conditions that may arise (equipment issues, opening deviations, inability to follow SOP, etc.)
• Understand where and how to escalate
• 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 best practices, e.g. regular Gemba Walks
• Occasional on-the-floor execution of unit operations
• 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
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree