Senior 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

We are seeking an Process Scientist to support peptide manufacturing in the Bay Area (Menlo Park). This role will serve as a technical process owner on the manufacturing floor, with a primary focus on Solid-Phase Peptide Synthesis (SPPS), synthesis, cleavage, purification, and lyophilization.

You will be responsible for monitoring, analyzing, troubleshooting, and continuously improving peptide manufacturing processes. This role partners closely with Manufacturing, Quality, and Engineering to improve yield and throughput, reduce process variability, support robust GMP operations, and drive data-based decision-making across the manufacturing process.

The ideal candidate brings strong peptide manufacturing or API process experience, a hands-on manufacturing mindset, and the ability to use process data, root cause analysis, and continuous improvement tools to improve manufacturing performance.

You Will:

• 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.

You Have:

• 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 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.