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Manufacturing Supervisor

Manufacturing Supervisor

LocationMassachusetts, United States
Business SectorBiotechnology
Contact nameAliyana Darwesh
Contact email
Job ref21409
Published5 months ago
Manufacturing Supervisor

Currently working with a Global Biotech Client who are in need of support from a Manufacturing Supervisor in Massachusetts, U.S. This is an opportunity to work with a global leader in Cell and Gene therapy transforming healthcare with ground-breaking technology.
Interview + offer will take place this week and next, so get in touch ASAP if interested.

Primary Responsibilities:
  • Supervise, train, and mentor the upstream, downstream, drug product, and banking(Cell/Virus) teams. 
  • Create a high-performance environment that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
  • Primary contact for troubleshooting and issue resolution or escalation
  • Ensure documentation is complete, reviewed, and meets good documentation practices 
  • Monitor material consumption and coordinate all materials deliveries with the Supply chain and MFG management
  • Recommend/Implement process changes/improvements or safety/ergonomic improvements.
  • Ensure continuous state of readiness for production and GMP audits.
  • As a system owner of all manufacturing equipment, monitor CMS alarms, including off-hours and weekends. 
  • Assist pilot plant supervisor in ensuring schedule ready for MFG clean room and pilot plant operations and share direct reports responsibilities to manage the workload. 

People & Training:
  • Ensure appropriate staffing levels and skills are maintained   
  • Manage employee performance issues and corrective actions 
  • Ensure staff compliance with all relevant SOPs, BPR’s, SLR’s and safety guidelines
  • Act as a resource/SME for staff
  • Conduct training and assess the effectiveness
  • Help identify training needs and assess staff skill-sets
  • Provide and develop training materials on process operations, theory, and compliance.          
  • Write Quality Indicators and implement appropriate corrective actions
  • Complete action items for GMP investigations and CAPA’s
  • Assist manufacturing management and other cross-functional teams with investigations              
  • Communicate quality issues/concerns to MFG management and QA
  • Organizes and participates on cross-functional continuous improvement teams such as Engineering, Validation, QA, QC, Facilities, and Process development
  • Supporting ownership of calibration and maintenance events for all Manufacturing owned equipment

  • Bachelor’s degree in Life Sciences/Engineering field with 3-5 years of cGMP experience 
  • Prior leadership experience in GMP manufacturing facility.
  • Previous experience in a comparable position preferentially in an industrial organization 
  • Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures 
  • Experience completing moderate to complex schedules
  • Experience in (bio)-manufacturing unit operations 
  • The work schedule may require adjustments to support production activities. 

Position: Manufacturing Supervisor
Location: MA, United States
Start Date: Immediately or by agreement