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Manufacturing Operations Supervisor

2 months ago

Durham, North Carolina, United States KBI Biopharma Full time

Job Overview

The Manufacturing Operations Supervisor plays a crucial role in guiding a team of production associates engaged in the upstream or downstream processing of bulk intermediates and/or bulk drug substances within the biopharmaceutical sector. This position involves planning, assigning, and overseeing daily activities to ensure efficient execution while adhering to safety and quality standards, including current Good Manufacturing Practice (cGMP).

In addition to routine responsibilities, the Supervisor will spearhead project teams, develop standard operating procedures (SOPs) and Master Batch Records (MBRs), implement corrective and preventive actions (CAPAs), and support the qualification of facilities and equipment.

A successful Supervisor will leverage their knowledge of upstream and downstream processing equipment to mentor team members, resolve issues, and optimize daily operations. Furthermore, the Supervisor will oversee personnel responsible for maintaining GMP facilities.

Key Responsibilities include:

  • Planning and scheduling daily production activities.
  • Facilitating manufacturing processes.
  • Ensuring adherence to established procedures.
  • Supervising and training team members.
  • Overseeing the maintenance of equipment and facilities.
  • Driving initiatives for process improvement.

Qualifications for this role include a Bachelor's degree in a relevant field and several years of experience in cGMP manufacturing operations. Prior experience in leadership or supervisory capacities is advantageous. Essential skills include strong communication abilities, organizational proficiency, and a solid command of English for both reading and writing.