Biopharma GMP Manufacturing Lead & Process SME

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an experienced manufacturing operations professional to lead technical support on a 24/7 GMP biopharmaceutical manufacturing floor in Durham, NC.

You will drive new product introductions, draft batch records, mentor staff, and lead process-improvement projects while partnering with QA and Compliance to close deviations. The role requires a strong background in downstream operations, cell culture or fermentation, and a bachelor's degree with 6+ years of related

Qualifications

• Bachelor's degree in a related scientific or engineering discipline preferred.
• 6+ years of related experience and/or training or equivalent.
• Experience in downstream operations and cGMP manufacturing preferred.
• Fluent in English with strong written and verbal communication skills.
• Ability to work with minimal supervision in a fast-paced environment.

Responsibilities

• Lead technical support activities for GMP manufacturing operations.
• Draft manufacturing batch records and procedures; support changes.
• Support new product/process introductions and facility fit.
• Coach and mentor manufacturing associates; support trainers.
• Drive process improvements and lead CAPA initiatives.
• Coordinate deviations investigations with QA/compliance.
• Support Operational Excellence initiatives (5S, lean).
• Ensure safety, quality, and regulatory requirements on the shop floor.

Skills

Downstream operations knowledge

Cell culture

Fermentation

GMP manufacturing

Leadership / mentoring

Process improvement

Quality & compliance awareness

English communication

Education

Bachelor's degree in science or engineering

Job description

KBI Biopharma, Inc. is seeking an experienced manufacturing operations professional to lead technical support on a 24/7 GMP biopharmaceutical manufacturing floor in Durham, NC.

You will drive new product introductions, draft batch records, mentor staff, and lead process-improvement projects while partnering with QA and Compliance to close deviations. The role requires a strong background in downstream operations, cell culture or fermentation, and a bachelor's degree with 6+ years of related