Contract Senior Biologics Process Development Engineer

Keros Therapeutics; Lexington (VA); On-site; USD 154,291 - 170,822; Full time

Job summary

Keros Therapeutics is seeking a Contract Senior Process Development Engineer in the United States to lead biologics process development across upstream and downstream operations, scale-up, and technology transfer. You will work with internal teams and external CDMOs to ensure seamless cGMP manufacturing transitions and robust process performance.

The role requires extensive hands-on experience, strong data analysis, and a track record of successful regulatory submissions.

Qualifications

• Experience in biologics process development and technology transfer.
• Hands-on aseptic technique and mammalian cell culture maintenance.
• Regulatory submission support and cGMP manufacturing exposure.

Responsibilities

• Lead transfer of processes to multiple bioreactor types and scales.
• Provide upstream and downstream leadership for development programs.
• Perform experiments and optimize scalable process strategies.
• Coordinate with CDMOs for tech transfer and regulatory support.
• Develop documentation for protocols and master batch records.
• Drive continuous process improvement using data analysis.

Skills

Biologics process development

Scale-up principles

Mammalian cell culture

Aseptic technique

Education

BS with 10+ yrs or MS with 8+ yrs or PhD with 5+ yrs in biologics

Tools

Bioreactors

Control systems

Process data analysis

Job description

Keros Therapeutics is seeking a Contract Senior Process Development Engineer in the United States to lead biologics process development across upstream and downstream operations, scale-up, and technology transfer. You will work with internal teams and external CDMOs to ensure seamless cGMP manufacturing transitions and robust process performance.

The role requires extensive hands-on experience, strong data analysis, and a track record of successful regulatory submissions.