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