Senior Upstream Manufacturing Leader

KBI Biopharma, Inc.; Durham (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an Upstream Director to oversee all upstream manufacturing activities at a new GMP biopharmaceutical facility.

The role drives quality, safety, productivity and cost objectives while guiding media preparation, seed expansion, bioreactor operations and harvest processes. The successful candidate will manage staff, ensure compliance with batch records and SOPs, lead capital projects, schedule planning and continuous improvement initiatives, and mentor a

Qualifications

• B.S. in life sciences or engineering with 15+ years GMP manufacturing ops, or a Master's with 13+ years.
• 7+ years of leadership or supervisory experience.
• Cell culture or fermentation operations knowledge preferred.
• Single-use platform technology experience preferred.
• Excellent written and verbal communication skills.

Responsibilities

• Plan, schedule and support medium and long term production tasks to meet the schedule.
• Hire, train and develop a motivated, high-performing team.
• Lead audits, change controls, CAPAs and ensure cGMP compliance.
• Drive process improvements and troubleshoot equipment and processes.
• Ensure readiness during construction, commissioning and qualification.

Skills

Leadership

GMP

Cell culture

Process improvement

Team coaching

Education

B.S. in Life Sciences or Engineering

M.S. in Life Sciences or Engineering

Tools

ERP

EDMS

MS Office

Job description

KBI Biopharma, Inc. is seeking an Upstream Director to oversee all upstream manufacturing activities at a new GMP biopharmaceutical facility.

The role drives quality, safety, productivity and cost objectives while guiding media preparation, seed expansion, bioreactor operations and harvest processes. The successful candidate will manage staff, ensure compliance with batch records and SOPs, lead capital projects, schedule planning and continuous improvement initiatives, and mentor a