Process Development Engineer - Peptide Manufacturing

About the role

PolyPeptide partners with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. It is looking for a Process Development Engineer (Development Scale-Up Engineer) in Torrance, CA, to bridge the gap between process development and full-scale manufacturing. The role suits a technically strong chemical engineer who solves complex process challenges, works closely with chemists and uses data-driven approaches to improve yield, efficiency, throughput and manufacturing performance.

Key responsibilities

• Scale up and scale down unit operations in peptide manufacturing, supporting the move from laboratory to pilot and production scales.
• Work closely with chemists to understand process requirements, challenges and constraints, and support process transfer from process development to full-scale manufacturing.
• Apply data analysis and Design of Experiments (DOE) to identify bottlenecks, reduce waste and improve yields.
• Develop steady-state process simulation models using physical property data to predict system performance under varying operating conditions.
• Perform cost and capacity analyses to optimize production efficiency and material output.
• Support new product introductions and manufacturing transfer activities, and improve process capability, yield, throughput, cycle time and manufacturing costs.
• Apply Lean Manufacturing, Six Sigma, DOE, SPC and other continuous improvement tools, and look for automation and waste reduction opportunities.
• Ensure work complies with safety, quality, regulatory and company requirements.
• Report directly to the Head of Process Development.

Required profile

• Master's degree in Chemical Engineering or a related field.
• Experience in process development, scale-up, scale-down or manufacturing support in a chemical, pharmaceutical, biotech or related environment.
• Experience in peptide manufacturing is highly beneficial; experience in a GMP-regulated environment and with quality systems is preferred.
• Experience supporting technology transfer, new product introduction or manufacturing optimization is a plus.

Required skills

• Strong understanding of chemical engineering principles and unit operations.
• Knowledge of filtration, chromatography, crystallization and other manufacturing unit operations.
• Experience with scale-up and scale-down of chemical processes.
• Data analysis, DOE, SPC and process modeling; cost, capacity, yield, throughput and efficiency evaluations.
• Familiarity with Lean Manufacturing, Six Sigma and continuous improvement is preferred.