Senior Downstream Bioprocess Engineer

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 118,000 - 178,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, and vision coverage

PTO and holidays

401K with vesting

Job summary

KBI Biopharma, Inc. in Boulder, Colorado, seeks a Senior Engineer for Manufacturing Science and Technology to lead downstream technology transfer, document authoring, and plant support for client programs.

This role requires collaboration across Facilities, Process Development, Supply Chain, Quality, and Manufacturing to ensure efficient project execution. You will serve as downstream SME for chromatography, filtration, and related operations, review critical documents, manage cross-functional

Qualifications

• Bachelor’s degree in chemical engineering, biochemical engineering, or related field.
• 11+ years of experience in bioprocess development or manufacturing in biotech/biopharma.
• Expertise in biologics, cell therapy, gene therapy, and drug substance production.
• Strong understanding of cGMP, FDA/EMA guidelines, and validation principles.
• Demonstrated leadership in cross-functional teams and project management.
• Excellent communication, analytical, and problem-solving skills.
• Experience with regulatory submissions (IND, BLA, MAA) is a plus.

Responsibilities

• Provide process engineering ownership for product transfer and implementation decisions.
• Subject Matter Expert for downstream drug substance operations (chromatography, TFF, clarification, filtration).
• Review and approve technical documents including process descriptions and validation reports.
• Generate technical solutions and leverage external expertise.
• Possibly supervise project resources and delegate work.
• Support 24/7 plant operations on a rotating basis.

Skills

Bioprocess development

Biopharma industry

Biologics

cGMP compliance

Regulatory submissions

Project management

Cross-functional leadership

Communication skills

Analytical skills

Problem solving

Education

Bachelor’s in chemical engineering / Biochemical Engineering

Job description

KBI Biopharma, Inc. in Boulder, Colorado, seeks a Senior Engineer for Manufacturing Science and Technology to lead downstream technology transfer, document authoring, and plant support for client programs.

This role requires collaboration across Facilities, Process Development, Supply Chain, Quality, and Manufacturing to ensure efficient project execution. You will serve as downstream SME for chromatography, filtration, and related operations, review critical documents, manage cross-functional