Manufacturing Support Supervisor

Supervision & Leadership

• Provide day-to-day supervision and guidance for the manufacturing support team, reinforcing safe, efficient, and compliant execution of assigned operations
• Assign and coordinate daily workload and priorities across media preparation, material kitting, GMP cleaning, and related support activities to meet production demand
• Maintain routine floor presence and conduct shift huddles to communicate priorities, monitor progress, and reinforce standard work and cGMP behaviors
• Provide coaching and on-the-job guidance; document observations and communicate recurring performance concerns to management/HR for follow-up as needed
• Promote a culture of safety, quality, and accountability through clear expectations, timely feedback, and consistent follow-through

Production & Scheduling

• Coordinate end-of-day cleaning activities to support next-day readiness; ensure tasks are executed and documented and communicate any missed activities and recovery needs
• Coordinate daily/weekly support execution (materials, media, and cleaning) to align with the production plan; communicate readiness and issues to the appropriate stakeholders
• Partner with the Manufacturing Scheduler to align priorities and communicate schedule impacts and constraints; support mitigation actions as directed
• Coverage shift coverage (including time-off coverage) and communicate coverage risks to management; support coverage plans to minimize impact to operations
• Support timely task execution by removing routine barriers, adjusting priorities within the shift, and escalating issues that may impact schedule adherence
• Track and communicate shift performance items (e.g., completion status, documentation issues, and safety/quality observations) and escalate recurring issues for corrective action

Manufacturing Compliance

• Provide daily floor-level quality oversight for the support team by reinforcing procedures, safety expectations, and Quality System requirements
• Verify manufacturing documentation is completed correctly and on time, including Batch Records and Electronic Batch Records (EBRs); coordinate timely correction of errors and coaching to prevent recurrence
• Review batch records, SOPs, and logbooks for accuracy and completeness; route documentation per procedure and promptly escalating discrepancies to Quality and Manufacturing management
• Support internal and external audits and inspections by ensuring documentation readiness for the shift and by completing assigned follow-up actions within required timelines

System & Documentation Management

• Perform and verify accurate ERP transactions supporting manufacturing execution (e.g., material requisitions/allocation, production tracking, and work order updates)
• Oversee documentation-related workstreams (labels, EBR updates, media and materials requests), ensuring prioritization, accuracy, and on-time completion
• Author and updated controlled documents (e.g., SOPs, deviations, protocols) in alignment with GMP requirements; route completed documents for review and approval through the appropriate Quality Systems workflow
• Ensure training records are current and audit-ready; verify team compliance with required curricula, certifications, and role-based qualification plans

Continuous Improvement & Operational Efficiency

• Collaborate with cross-functional stakeholders to identify operational risks, capacity constraints, and resource needs; escalate findings and support mitigation plans as directed
• Coordinate evaluation and implementation of new materials and equipment by defining user requirements, supporting trials, and confirming readiness for GMP use
• Maintain visibility to improvement ideas, deviations/operational issues, and employee concerns; track progress and escalate unresolved items to leadership
• Participate in and support continuous improvement activities (standardization, 5S, waste reduction, error-proofing) to improve safety, quality, and cycle time
• Participate in cross-functional projects as a team representative to support manufacturing support capability and business continuity

Team Development & Training

• Provide training support for material kitting and cleaning (as a trainer and/or by coordinating with qualified trainers) to support consistent execution to approved procedures
• Coach employees on standard work and GMP expectations; reinforce good practices through routine observations and feedback
• Coordinate with Training to schedule and complete required curricula; identify training gaps and communicate needs and impacts to management
• Monitor training completion and communicate non-compliance or qualification risks; support recovery actions as directed
• Support onboarding and orientation for new team members by coordinating training plans and documenting progress toward role qualification milestones

Administrative & Communication Responsibilities

• Manage shift handoffs and coverage changes, assign daily responsibilities, and represent the team in daily/departmental communications as needed
• Communicate status, risks, and needs to the manager and partner departments to support timely issue resolution in a fast-paced manufacturing environment
• Provide clear, timely written communication (emails, shift updates, and documentation) to ensure alignment and traceability

Qualifications

• Education / Training: Bachelor’s degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering)
• Experience/Education: AS/BS in Biotechnology, Biology, Chemistry or equivalent; Minimum 4+ years of experience in a manufacturing or GMP environment; 2+ years of experience in lead, training, or coordination role
• Knowledge/Skills: Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements; Familiarity with ERP systems (Sage X3 or similar) and document management systems; Good communication, leadership, and problem-solving skills; Ability to work in a fast-paced environment while maintaining high standards of quality and compliance; Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols)