The manufacturing support manager will oversee the management of the manufacturing support activities in support of the startup and production at a new clinical GMP biopharmaceutical manufacturing facility.  The individual will lead the manufacturing support team with the aim of achieving superior quality, safety, productivity and cost objectives.  The individual will lead the manufacturing readiness activities during the construction, commissioning, and qualification of the facility.  The manager will oversee all manufacturing support staff, with manufacturing supervisors and specialists as direct reports and will report to the VP Manufacturing Operations.

This proven and qualified candidate will use their past experiences, depth and knowledge of manufacturing support equipment such as autoclaves, media and buffer preparation equipment and operations to teach, troubleshoot and continuously improve the production operations. Additionally, the individual will oversee the activities related for cleaning the manufacturing clean room facility.  The ideal candidate will be both technically sound as well as an experienced team motivator and coach.
The individual will ensure their teams maintain strict accordance with production batch records, SOPs and Good Manufacturing Practices.

The individual will also be responsible for ensuring MRP transactions, manufacturing record reviews, maintenance activities, and compliance documents are completed timely and thoroughly.  The individual will ensure that manufacturing records and materials are available for timely execution of activities to meet production schedules.

In this position, the Manager will ensure the department personnel maintains strict accordance with SOP’s, PAR’s, Good Manufacturing Practices, Good Documentation Practices and adhere to all safety procedures and precautions.

The individual will be responsible for managing the mid-term and long-term schedule planning for their department and be the primary point of contact for daily issue escalation. 

The manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.
 

• Plan, schedule, and support medium and long term production tasks to ensure schedule adherence. 
• Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
• Maintaining the cleanroom environments within the GMP Facility by managing and organizing the required cleanings (daily/weekly/monthly/changeover cleanings) coordinating responses with environmental excursions, building process assemblies, managing process waste from all departments and performing raw material sampling and dispensing
• Organize and coordinating room maintenance per each program (Calibrations, PM’s, Work Orders and Corrective actions) with Facility Engineering and schedule and support task with external department/venders with work orders related to GMP rooms and equipment.  
• Scheduling and Coordinating of Process waste and Raw Material Sampling. Troubleshoot issues that may arise.
• Ensure timely execution and review of procedures, batch documentation, logbooks, deviations, CAPAs, change controls, and completion of ERP orders.  Drive requirements to ensure rapid batch disposition.  
• Hire, train and develop a highly motivated and engaged high performing team.  Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.  Serve as a SME during internal and external audits and inspections.
• Ensure equipment and manufacturing facilities remain in superior working order by demonstrating a clear sense of ownership, accountability, and pride by performing routine walkthroughs, setting high standards for their staff, and ensuring facility and equipment work orders are executed timely and effectively.
   
• Additional responsibilities include, but not limited to, the oversight of:
• Routine cleaning of the cleanroom environments within the GMP Facility,
• Process assembly builds
• Management of process waste 
• Raw material sampling. 
• Personnel training
• Cross-Functional Collaboration: Coordinating and collaborating with upstream/downstream manufacturing, Quality, Facilities and QC to ensure production schedule and facility requirements are met.

MINIMUM REQUIREMENTS

• B.S. degree in a life sciences or engineering discipline and 9+ years’ experience in related GMP manufacturing operations or a Master’s degree and 7+ years’ experience in related GMP manufacturing operations.  Level commiserate with education and experience.
• 3+ years prior leadership/supervisory experience. 
• Demonstrated knowledge of cell culture or fermentation unit operations are preferred. Experience in single-use platform technology is preferred.  
• Excellent written and verbal communication skills are required.  
• Energetic, motivated and dynamic individual. 
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. 
• Fluent in French with English Language capabilities both reading and writing.  
• Computer Skills: MS Office, ERP, EDMS, production equipment software, other  
• Equipment Use: Biosafety Cabinets, Stainless Steel Preparation Vessels, Single Use Mixers, Peristaltic Pumps and Other Single Use pumps, pH, conductivity, and Osmolality meters, other lab equipment, other production equipment, and Office Equipment.