Biopharma Manufacturing Specialist: Process & Training

NCBioImpact; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is hiring for a GMP Manufacturing Support role focused on downstream operations and batch record management.

You will act as a technical SME for manufacturing processes, coaching shop floor staff and assisting in TRN development and training delivery. The role requires experience in cell culture/fermentation, familiarity with single-use platforms, and a degree in a related field or equivalent GMP manufacturing background.

Qualifications

• Knowledge of downstream operations, cell culture and/or fermentation.
• Experience with single-use platform technology is preferred.
• Bachelor's degree in a related scientific or engineering discipline preferred with 1+ year related experience and/or training; or equivalent GMP manufacturing experience.
• Requires minimal direction or supervision to execute routine tasks.
• Fluent in English with excellent written and verbal communication skills.

Responsibilities

• Perform New Product/Process Introduction and Changes including Facility Fit support.
• Draft, route, and revise manufacturing batch records, procedures and supporting records.
• Serve as technical SME in manufacturing operations and coach associates; support trainers in TRN development.
• Provide manufacturing process support during ongoing shop floor execution.
• Engage with Associates and Supervisors to identify barriers and drive improvement projects.
• Lead CAPA implementations and partner with Compliance/QA for Deviations investigations.
• Support Operational Excellence initiatives including 5S, Lean Manufacturing, and standardization.
• Support safety, compliance and quality requirements.

Skills

Downstream operations

Cell culture

Fermentation

Single-use platform

Communication skills

Education

Bachelor's degree or equivalent GMP experience

Job description

KBI Biopharma, Inc. in Durham, NC, is hiring for a GMP Manufacturing Support role focused on downstream operations and batch record management.

You will act as a technical SME for manufacturing processes, coaching shop floor staff and assisting in TRN development and training delivery. The role requires experience in cell culture/fermentation, familiarity with single-use platforms, and a degree in a related field or equivalent GMP manufacturing background.