Senior Process Engineer – Downstream (Biologics & Peptides)

Job Title: Senior Process Engineer Downstream (Biologics & Peptides)

Location: Boulder CO (100% Onsite)

Duration: 6 Months Extensions

Start Date: ASAP

Job Summary

We are seeking a Senior Process Engineer with strong expertise in downstream processing to support the development scale-up and commercialization of biologics and peptide-based therapeutics. This role will focus on designing optimizing and implementing purification processes and manufacturing systems within a GMP-regulated environment.

The ideal candidate will have hands-on experience with chromatography and tangential flow filtration (TFF) technologies along with a proven track record supporting process scale-up equipment qualification and manufacturing startup activities.

Key Responsibilities

• Lead downstream process development and optimization activities for biologics and peptide products
• Design specify and support implementation of purification systems including chromatography and TFF skids
• Support process scale-up from development through pilot and commercial manufacturing
• Drive startup commissioning qualification and troubleshooting of downstream manufacturing equipment
• Develop and execute process validation and verification strategies aligned with GMP and regulatory requirements
• Collaborate with MSAT Upstream Manufacturing and Quality teams to ensure process robustness and consistency
• Author and review technical documentation including process descriptions validation protocols and regulatory support documents
• Serve as a technical SME for downstream purification operations and technologies
• Mentor junior engineers and support continuous improvement initiatives

Required Qualifications

• Bachelor s Master s or PhD in Chemical Engineering Biochemical Engineering or related field
• 8 years of experience in biopharmaceutical process engineering with strong downstream processing expertise
• Hands-on experience with:
• Chromatography systems (affinity ion exchange HIC etc.)
• Tangential Flow Filtration (TFF) systems
• Experience supporting equipment startup commissioning and qualification activities
• Strong understanding of process validation and GMP manufacturing environments
• Experience supporting or leading tech transfer and process scale-up activities
• Strong troubleshooting communication and cross-functional collaboration skills