Lead Peptide Manufacturing Process Engineer

Discover International; San Francisco (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Discover International in the San Francisco Bay Area seeks a Process Scientist to own SPPS peptide manufacturing on the shop floor, focusing on synthesis, purification, and lyophilization. You will monitor processes, analyze data, troubleshoot in real time, and drive continuous improvement with cross-functional teams to boost yield and throughput while maintaining cGMP compliance.

The ideal candidate has 3–7 years in peptide/API manufacturing, hands-on GMP experience, and strong data-analytic

Qualifications

• Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related field.
• 3–7 years of experience in pharmaceutical, biotechnology, peptide manufacturing, API manufacturing, or related chemical processing environments.
• Hands-on GMP manufacturing operations experience, investigations, and process validation activities.
• Direct experience with Solid-Phase Peptide Synthesis (SPPS).
• Experience analyzing manufacturing process data and implementing process improvements.
• Strong technical troubleshooting skills with root cause analysis and sustainable corrective actions.
• Experience authoring or revising GMP documentation (SOPs, batch records, deviation investigations, CAPAs, change controls, risk assessments).
• Strong cross-functional collaboration and communication with Manufacturing, Quality, Engineering, and Supply Chain.

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 KPIs across peptide manufacturing processes.
• Collect, analyze, and trend manufacturing data to identify process variability and yield losses.
• Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, and right-first-time metrics.
• Evaluate coupling efficiency, resin performance, deprotection efficiency, and impurity formation trends related to SPPS.
• Identify and implement improvements to reaction conditions, cycle parameters, and process controls.
• Lead initiatives to improve product yield, throughput, cycle time, and overall equipment effectiveness.
• Apply Lean, Six Sigma, and statistical analysis to reduce waste and process variation.
• Lead or support investigations related to process excursions, 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, and technical reports.
• Support deviation investigations, CAPAs, change controls, risk assessments, and process validation.
• Ensure technical documentation is accurate, complete, and compliant with cGMP.
• Partner with Operations, Engineering, Quality, and Supply Chain to improve performance.
• Support implementation of new equipment, technologies, and manufacturing systems.
• Participate in production planning and process improvement meetings.
• Provide technical mentoring and training to manufacturing personnel.

Skills

Cross-functional collaboration

Technical troubleshooting

Data analysis

Root cause analysis

Communication skills

Education

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

Tools

Minitab

Power BI

Excel (Advanced Analytics)

Job description

Discover International in the San Francisco Bay Area seeks a Process Scientist to own SPPS peptide manufacturing on the shop floor, focusing on synthesis, purification, and lyophilization. You will monitor processes, analyze data, troubleshoot in real time, and drive continuous improvement with cross-functional teams to boost yield and throughput while maintaining cGMP compliance.

The ideal candidate has 3–7 years in peptide/API manufacturing, hands-on GMP experience, and strong data-analytic