Senior Process Engineer – Downstream (Biologics & Peptides)

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.

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