Bioprocess Engineering Lead: Scale-Up & Transfer

FS; St. Louis (MO); On-site; USD 140,000 - 160,000; Full time

Job summary

AgraForm LLC in St. Louis, MO seeks a Principal Bioprocess Engineer to lead the design, start-up, scale-up, and optimization of bioprocess systems across fermentation and downstream operations.

The role involves driving CPPs/CQAs, CAPA, DoE plans, and technology transfer to ensure safe, reliable, and compliant manufacturing. You will oversee qualification activities, establish process controls, and collaborate with cross-functional teams to deliver high-quality biologics manufacturing

Qualifications

• Bachelor's degree in chemical engineering, Biochemical Engineering, Biotechnology, or related engineering; Master's or PhD preferred, and seven+ years in bioprocess engineering or related fields.

Responsibilities

• Lead IQ/OQ/PQ for all fermentation and downstream processing equipment.
• Design, optimize, and scale-up fermentation processes from bench/pilot to full production across bioreactor platforms.
• Establish and maintain CPPs and CQAs for each microbial product line.
• Lead root-cause analysis and CAPA for deviations, contamination events, or yield excursions.
• Lead process risk assessments (HAZOPs, PHAs) and ensure designs comply with EHS/regulatory requirements.
• Author and maintain MBRs, SOPs, validation protocols, and regulatory dossiers.
• Act as SME for biological manufacturing processes and support routine operations and troubleshooting.
• Serve as primary contact for bioreactor OEMs and CIP/SIP integrators.
• Develop DoE plans and technology transfer packages.
• Develop, review, and approve PFDs, P&IDs, mass/energy balances, equipment specs, control philosophies, and process descriptions.
• Maintain sterility assurance programs including environmental monitoring and cleaning validation.
• Develop preventive maintenance schedules and support capital projects.
• Support scale-up and tech transfer from R&D to commercial production.
• Monitor process performance data to ensure operations stay within control limits and identify improvements.
• Define packaging specs and cold chain/ambient requirements with supply chain.

Job description

AgraForm LLC in St. Louis, MO seeks a Principal Bioprocess Engineer to lead the design, start-up, scale-up, and optimization of bioprocess systems across fermentation and downstream operations.

The role involves driving CPPs/CQAs, CAPA, DoE plans, and technology transfer to ensure safe, reliable, and compliant manufacturing. You will oversee qualification activities, establish process controls, and collaborate with cross-functional teams to deliver high-quality biologics manufacturing