Manager​/Senior Manager, Manufacturing Support

JOB SUMMARY

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 to achieve superior quality, safety, productivity, and cost objectives, reporting to the Director of Manufacturing. The role will manage all manufacturing support staff, including manufacturing supervisors and the solution prep planner, and will be responsible for ensuring strict adherence to production batch records, SOPs, and Good Manufacturing Practices.

Additional duties include overseeing staff responsible for cleaning the manufacturing facility, ensuring timely completion of MRP transactions, manufacturing record reviews, maintenance activities, and compliance documents.

• 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 performing routine walkthroughs, setting high standards for staff, and ensuring facility and equipment work orders are executed timely and effectively.

• 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.
• 7+ years prior leadership/supervisory experience.
• Demonstrated understanding of biopharmaceutical manufacturing and cGMP requirements; experience in single‑use platform technology is preferred.
• Excellent written and verbal communication skills.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a fast‑paced, multi‑tasked environment while maintaining operational efficiency and a positive demeanor.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status, are strongly encouraged to apply.