Night-Shift Biopharma Manufacturing Supervisor

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 98,000; Full time

Job summary

The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products.

The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP).

Qualifications

• Bachelor’s degree in related scientific or engineering discipline with 4+ years in cGMP manufacturing.
• Knowledge of mammalian cell culture or purification operations preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Supervise and coach manufacturing associates, ensuring Right First Time execution.
• Review manufacturing procedures and train personnel for accuracy and compliance.
• Drive process improvements, troubleshoot issues, and manage CAPAs and deviations.
• Coordinate with MS&T, PD, QA, Maintenance, Facilities, and Microbiology for batch support.
• Oversee documentation, logbooks, and ERP orders to maintain schedule adherence.
• Ensure equipment and facilities remain in proper working order and safe operation.

Skills

Communication

cGMP knowledge

Education

Bachelor’s degree in related scientific or engineering discipline

High school degree + 10 years’ experience

Job description

The Manufacturing Supervisor, Solution Prep leads a team of manufacturing associates to perform both upstream and downstream preparation of solutions and growth media used for processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products.

The individual will plan, assign, and monitor daily tasks to ensure timely “Right First Time” execution and strict compliance with safety and quality regulations, e.g., current Good Manufacturing Practice (cGMP).