Senior Peptide Process Engineer - Lean, Data-Driven Ops

Katalyst CRO; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO seeks a technical process owner for peptide manufacturing (SPPS, purification, lyophilization) to support batch execution and provide real-time troubleshooting on the floor. You will monitor critical parameters and KPIs, collect and trend data to identify variability and bottlenecks, and develop dashboards tracking yield and cycle times.

The role emphasizes Lean Six Sigma, root cause analysis, and cGMP documentation, with collaboration across Operations, Engineering, Quality, and

Qualifications

• Bachelor's degree required in chemical-related field.
• 37 years of experience in pharmaceutical, biotechnology, peptide manufacturing, API manufacturing, or related chemical processing environments.
• Hands-on experience supporting GMP manufacturing operations, investigations, and process validation activities.
• Direct experience with Solid-Phase Peptide Synthesis.
• Experience analyzing manufacturing process data and implementing process improvements.
• Experience authoring or revising GMP documentation, including SOPs, batch records, technical reports, deviation investigations, CAPAs, change controls, or risk assessments.
• Strong cross-functional collaboration skills and the ability to work closely with Manufacturing, Quality, Engineering, and Supply Chain teams.
• Clear communication skills with the ability to translate technical process observations into actionable recommendations.

Responsibilities

• Serve as a technical process owner for peptide manufacturing operations, including SPPS, purification, and lyophilization.
• Support batch execution on the floor with real-time troubleshooting.
• Monitor critical process parameters and KPIs across peptide manufacturing processes.
• Collect, analyze, and trend manufacturing data to identify variability, yield losses, bottlenecks, and opportunities.
• Develop dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics.
• Lead improvements to reaction conditions, cycle parameters, and process controls.
• Lead initiatives to improve yield, throughput, cycle time, OEE, and robustness.
• Apply Lean Manufacturing, Six Sigma, statistical analysis, and root cause analysis tools to reduce waste and variation.
• Lead or support investigations related to process excursions, atypical results, yield losses, deviations, and equipment issues.
• Use Fishbone, 5 Why, FMEA, and SPC to drive corrective actions.
• Author and revise SOPs, Master Batch Records, process descriptions, manufacturing instructions, reports, and summaries.
• Support deviation investigations, CAPAs, change controls, risk assessments, validation, and CPP activities.
• Ensure documentation is accurate and compliant with cGMP.
• Partner with Operations, Engineering, Quality, Supply Chain, and site leadership to improve performance.
• Support implementation of new equipment, technologies, and manufacturing systems.
• Participate in production planning, operational excellence reviews, and process improvement meetings.
• Provide technical mentoring and training to personnel on process understanding and best practices.

Skills

Lean Manufacturing

Six Sigma

Root Cause Analysis

Statistical Process Control

Cross-functional Collaboration

Process Optimization

Education

Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field

Master's degree or Ph.D. in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or related field

Tools

Minitab

Power BI

Excel (advanced analytics)

Job description

Katalyst CRO seeks a technical process owner for peptide manufacturing (SPPS, purification, lyophilization) to support batch execution and provide real-time troubleshooting on the floor. You will monitor critical parameters and KPIs, collect and trend data to identify variability and bottlenecks, and develop dashboards tracking yield and cycle times.

The role emphasizes Lean Six Sigma, root cause analysis, and cGMP documentation, with collaboration across Operations, Engineering, Quality, and