Lead Downstream Biologics Process Engineer

KBI Biopharma, Inc.; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an MS&T Senior Engineer - Downstream to drive efficiency, quality, and innovation in downstream biologics processing.

You will support cGMP production operations, lead process improvements, and oversee technology transfer and validation while collaborating with cross‑functional teams and clients. The role emphasizes technical leadership, regulatory compliance, and the ability to troubleshoot complex downstream processes to ensure successful scale‑up and transfer to

Qualifications

• Bachelor’s degree in science or engineering with 9+ years of industry experience OR Master’s with 7+ years OR PhD with 5+ years.
• Expertise in biologics, downstream processing, tech transfer, and operational support; strong cGMP background and regulatory awareness.

Responsibilities

• Provide technical support and process ownership for cGMP downstream operations and transfer from development to manufacturing.
• Act as primary client liaison, defining process requirements and ensuring alignment on design, transfer plans, and performance criteria.
• Lead cross‑functional teams across Manufacturing, Validation, QA, Facilities & Engineering, IT, and Process Development to implement improvements and ensure compliant execution.

Skills

Biologics downstream processing

Technology transfer

Process validation

cGMP operations

Team leadership

Education

Bachelor’s degree in science or engineering

Master’s degree

PhD

Job description

KBI Biopharma, Inc. is seeking an MS&T Senior Engineer - Downstream to drive efficiency, quality, and innovation in downstream biologics processing.

You will support cGMP production operations, lead process improvements, and oversee technology transfer and validation while collaborating with cross‑functional teams and clients. The role emphasizes technical leadership, regulatory compliance, and the ability to troubleshoot complex downstream processes to ensure successful scale‑up and transfer to