Sr Process Engineer

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

• Serve as a technical process owner for peptide manufacturing operations, including SPPS, purification, and lyophilization.
• Support manufacturing teams during batch execution and provide real-time technical troubleshooting on the floor.
• Monitor critical process parameters and key performance indicators across peptide manufacturing processes.
• Collect, analyze, and trend manufacturing data to identify process variability, yield losses, bottlenecks, and improvement opportunities.
• Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics.
• Evaluate coupling efficiency, resin performance, deprotection efficiency, impurity formation trends, and other process indicators related to SPPS performance.
• Identify and implement improvements to reaction conditions, cycle parameters, manufacturing practices, and process controls.
• Lead initiatives to improve product yield, throughput, cycle time, overall equipment effectiveness, and process robustness.
• Apply Lean Manufacturing, Six Sigma, statistical analysis, and structured root cause analysis tools to reduce waste and process variation.
• Lead or support investigations related to process excursions, atypical results, yield losses, manufacturing deviations, and equipment/process issues.
• Use tools such as Fishbone Analysis, 5 Why Analysis, FMEA, and Statistical Process Control to identify root cause and drive corrective actions.
• Author and revise SOPs, Master Batch Records, process descriptions, manufacturing instructions, technical reports, and process performance summaries.
• Support deviation investigations, CAPAs, change controls, risk assessments, process validation, and continued process verification activities.
• Ensure technical documentation is accurate, complete, and compliant with cGMP requirements.
• Partner cross-functionally with Operations, Engineering, Quality, Supply Chain, and site leadership to improve manufacturing 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 manufacturing personnel on process understanding and best practices.

Roles And Responsibilities

• Serve as a technical process owner for peptide manufacturing operations, including SPPS, purification, and lyophilization.
• Support manufacturing teams during batch execution and provide real-time technical troubleshooting on the floor.
• Monitor critical process parameters and key performance indicators across peptide manufacturing processes.
• Collect, analyze, and trend manufacturing data to identify process variability, yield losses, bottlenecks, and improvement opportunities.
• Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics.
• Evaluate coupling efficiency, resin performance, deprotection efficiency, impurity formation trends, and other process indicators related to SPPS performance.
• Identify and implement improvements to reaction conditions, cycle parameters, manufacturing practices, and process controls.
• Lead initiatives to improve product yield, throughput, cycle time, overall equipment effectiveness, and process robustness.
• Apply Lean Manufacturing, Six Sigma, statistical analysis, and structured root cause analysis tools to reduce waste and process variation.
• Lead or support investigations related to process excursions, atypical results, yield losses, manufacturing deviations, and equipment/process issues.
• Use tools such as Fishbone Analysis, 5 Why Analysis, FMEA, and Statistical Process Control to identify root cause and drive corrective actions.
• Author and revise SOPs, Master Batch Records, process descriptions, manufacturing instructions, technical reports, and process performance summaries.
• Support deviation investigations, CAPAs, change controls, risk assessments, process validation, and continued process verification activities.
• Ensure technical documentation is accurate, complete, and compliant with cGMP requirements.
• Partner cross-functionally with Operations, Engineering, Quality, Supply Chain, and site leadership to improve manufacturing 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 manufacturing personnel on process understanding and best practices.

Education And Experience

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a 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.
• Strong technical troubleshooting skills with the ability to identify root cause and implement sustainable corrective actions.
• 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.

Nice To Have

• Master's degree or Ph.D. in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related field.
• Experience in commercial-scale peptide manufacturing.
• Experience with process monitoring, Statistical Process Control, and process capability assessments.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience using statistical software and data analysis tools such as Minitab, Power BI, Excel advanced analytics, or similar tools.
• Experience in a startup or rapidly growing manufacturing organization.