GMP Manufacturing Specialist I/II - Process Excellence

KBI Biopharma, Inc.; Durham (NC); On-site; USD 60,000 - 78,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Technical Support Specialist for GMP Manufacturing Operations in a multi-product biopharma facility.

You will support downstream operations, draft manufacturing records, and act as SME to coach associates while driving process improvements on the shop floor. The role requires writing and routing batch records, supporting TRNs, deviations, and participation in Operational Excellence initiatives including 5S, Lean, and standardization.

Qualifications

• Demonstrated knowledge of downstream operations, cell culture and/or fermentation.
• Experience with single-use platform technology preferred.
• Bachelor’s degree in a related scientific or engineering discipline with 1+ year of GMP manufacturing experience or training.
• Requires minimal direction for routine tasks.
• Fluent in English with excellent written and verbal communication skills.
• Detail oriented, good time management and customer focus.

Responsibilities

• Provide technical support for GMP manufacturing operations in a multi-product facility.
• Draft, route and revise manufacturing batch records and procedures.
• Support new product/process introductions and changes, including facility fit and equipment modifications.
• Act as technical SME, coaching manufacturing associates and supporting trainers in TRN development.
• Support shop floor execution and manufacturing process improvements.
• Drive corrective and preventive actions and manage deviations in collaboration with QA.
• Contribute to Operational Excellence initiatives: 5S, Lean, standardization, and safety.

Skills

Downstream operations

Cell culture / fermentation

English communication

Education

Bachelor’s degree in related science/engineering

Job description

KBI Biopharma, Inc. in Durham, NC seeks a Technical Support Specialist for GMP Manufacturing Operations in a multi-product biopharma facility.

You will support downstream operations, draft manufacturing records, and act as SME to coach associates while driving process improvements on the shop floor. The role requires writing and routing batch records, supporting TRNs, deviations, and participation in Operational Excellence initiatives including 5S, Lean, and standardization.