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.
People & Training:
- 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.
- 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.
MA, United States
Immediately or by agreement