Senior Downstream Process Engineer

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

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.

• 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

• Bachelors/Masters/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

• 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

• Downstream Processing
• Biologics & Peptides
• Chromatography
• TFF Systems
• GMP Manufacturing
• Process Validation
• Tech Transfer
• Commissioning & Qualification
• Process Scale-Up
• Troubleshooting
• MSAT Collaboration
• GLP-1 Therapeutics