Senior Downstream Bioprocess Engineer, cGMP & Tech Transfer

KBI Biopharma; Durham (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

KBI Biopharma seeks an experienced MS&T Senior Engineer - Downstream to drive efficiency, quality, and innovation in downstream biologics processing. You will support cGMP production, lead process improvements, and ensure regulatory standards are met across development to manufacturing transfer.

Ideal candidates bring a strong background in downstream operations, technical transfer, and validation, collaborating with multifaceted teams to deliver robust, scalable processes and high-quality

Qualifications

• Experience with biologics downstream or upstream processing and tech transfer.
• Strong knowledge of cGMP production operations and regulatory expectations.
• Proven ability to lead cross-functional teams and manage complex projects.

Responsibilities

• Provide technical ownership for cGMP downstream operations and tech transfer.
• Collaborate with QA, Validation, Manufacturing, and Process Development to implement improvements.
• Support client interactions and ensure process designs meet requirements and compliance.

Skills

Biologics processing

Tech transfer

cGMP operations

Process validation

Cross-functional leadership

Education

Bachelor’s degree in science or engineering

Master’s degree

PhD

Job description

KBI Biopharma seeks an experienced MS&T Senior Engineer - Downstream to drive efficiency, quality, and innovation in downstream biologics processing. You will support cGMP production, lead process improvements, and ensure regulatory standards are met across development to manufacturing transfer.

Ideal candidates bring a strong background in downstream operations, technical transfer, and validation, collaborating with multifaceted teams to deliver robust, scalable processes and high-quality