Senior Downstream Process Engineer

Job Title: Senior Downstream Process Engineer Location: Boulder, CO (Onsite – 5 days/week) Duration: 6 Months + Extensions Start Date: ASAP

Job Summary

Seeking a highly experienced Senior Process Engineer with strong expertise in downstream purification processes for biologics and peptide therapeutics. This role focuses on process development, scale-up, commissioning, and commercialization of purification systems with deep hands-on experience in chromatography and TFF technologies within GMP manufacturing environments.

Key Responsibilities

Lead downstream purification process development and optimization for biologics and peptide products

Design and support implementation of chromatography skids and TFF systems

Support process scale-up from development through commercial manufacturing

Drive equipment startup, commissioning, qualification, and troubleshooting activities

Develop process validation and verification strategies aligned with GMP requirements

Collaborate with MSAT, Manufacturing, Quality, and Upstream teams

Author technical documents including protocols, process descriptions, and regulatory support documentation

Serve as SME for downstream purification technologies

Mentor junior engineers and support continuous improvement initiatives

Required Qualifications

Bachelor’s/Master’s/PhD in Chemical Engineering, Biochemical Engineering, or related field

8+ years of biopharma process engineering experience focused on downstream purification

Strong experience with biologics and/or peptide purification processes

Hands-on expertise with:

Chromatography systems (Affinity, Ion Exchange, HIC)

Tangential Flow Filtration (TFF) systems

Experience supporting startup, commissioning, and qualification activities

Strong GMP process validation and verification knowledge

Experience with process scale-up and tech transfer activities

Preferred Qualifications

• Experience with peptide therapeutics or GLP-1 programs

• Prior work with large pharma companies such as Eli Lilly, Novo Nordisk, or Roche

• CDMO industry experience supporting multiple client programs

• Familiarity with single-use technologies and modern purification platforms

• Strong project leadership and stakeholder management skills

• Key Skills

• Downstream Processing

• Biologics & Peptides

• Chromatography

• TFF Systems

• GMP Manufacturing

• Process Validation

• Tech Transfer

• Commissioning & Qualification

• Process Scale-Up

• Troubleshooting

• MSAT Collaboration

• GLP-1 Therapeutics