Manager/Senior Manager, Manufacturing Support

KBI Biopharma • Durham, NC

69d

About The Position

The manufacturing support Manager/Sr Manager will oversee the manufacturing support activities including solution prep, finite scheduling for solution prep, material control and GMP cleaning. The individual will lead the manufacturing support team with the aim of achieving superior quality, safety, productivity and cost objectives. The role will oversee all manufacturing support staff, with manufacturing supervisors and the solution prep planner as direct reports, and will report to the Director of Manufacturing. 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 staff responsible for cleaning the manufacturing 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. 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.

Requirements

• B.S. degree in a life sciences or engineering discipline and 15+ years’ experience in related GMP manufacturing operations or a Master’s degree and 13+ years’ experience in related GMP manufacturing operations.
• Level commiserate with education and experience.
• 7+ years prior leadership/supervisory experience.
• Demonstrated understanding of biopharmaceutical manufacturing and cGMP requirements.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor, other production equipment, and Office Equipment.

Nice To Haves

• Experience in single-use platform technology is preferred.

Responsibilities

• 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, QA, Maintenance and Engineering, and AFS and Microbiology.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior