Manager, Manufacturing Specialists

KBI Biopharma • Durham, NC

93d

About The Position

The incumbent will oversee tech transfer activities for Upstream or Downstream Manufacturing and serve as the technical leader for the department. The Specialists’ Manager will oversee the Upstream or Downstream Manufacturing specialist team to ensure that Manufacturing tech transfer responsibilities are met to ensure ‘On-Time” and “Right the First time’ execution of production activities. The individual will oversee manufacturing record generation, equipment enrollment, operation, and maintenance, manufacturing projects and studies, and drive operational excellence initiatives for the department. The Specialists’ Manager will oversee Manufacturing Specialists and will report to the Director of Manufacturing Technical Operations. The individual will be responsible for managing mid-term and long-term manufacturing readiness planning and be the primary point of contact for daily issue escalation with respect to tech transfer and readiness tasks. The individual will ensure their team maintains strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for ensuring their staff work cross-functionally to ensure operations are both reliable and successful. This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable. This proven and qualified candidate will use their past experiences, depth and knowledge of fundamentals in media/buffer preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration/nanofiltration and drug substance filling operations to teach, troubleshoot and continuously improve the production operations of Manufacturing. The ideal candidate will be both technically sound as well as an experienced team motivator and coach. The Specialists’ Manager will use their leadership and technical expertise to drive process improvement initiatives, monitor processes and equipment and troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline
• 10+ years’ experience in related GMP manufacturing operations
• 6+ years prior leadership/supervisory experience
• Demonstrated knowledge of cell culture, fermentation, or purification unit operation is 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

Responsibilities

• Oversee manufacturing tech transfer activities including: Manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment
• Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed
• Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees
• Ensure staff maintain a high level of compliance to procedures and quality expectations
• Ensure equipment and Manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring vendor repairs as needed, maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair

Benefits

• Challenging and rewarding work environment
• Opportunity for career advancement through the development of technical skills
• Collaborative team environment where sharing knowledge and expertise is encouraged

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees