Senior Process Engineer – Downstream (Biologics & Peptides)

Stark Pharma; Boulder (CO); On-site; USD 100,000 - 140,000; Full time

Job summary

Stark Pharma is seeking a Senior Process Engineer Downstream in Boulder, CO. This role involves leading downstream process development for biologics and peptide therapeutics, focusing on purification processes within a GMP environment. Ideal candidates will have over 8 years of experience, a degree in Chemical Engineering or a related field, and hands-on knowledge of chromatography and TFF systems. The position is onsite and offers opportunities for involvement in process scale-up and mentoring junior staff.

Qualifications

• 8+ years of experience in biopharmaceutical process engineering with strong downstream processing expertise.
• Hands-on experience with chromatography and TFF systems.
• Strong understanding of GMP manufacturing environments.

Responsibilities

• Lead downstream process development and optimization for biologics and peptides.
• Design and support implementation of purification systems.
• Support process scale-up from the development to commercial manufacturing.

Skills

Downstream processing expertise

Chromatography systems

Tangential Flow Filtration (TFF)

Process validation

Troubleshooting skills

Education

Bachelor's, Master's, or PhD in Chemical Engineering or related field

Job description

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