Senior Process Development Engineer (API Scale-Up)

Ampac-Fine-Chemicals-1; Rancho Cordova (CA); On-site; USD 100,000 - 120,000; Full time

Job summary

Ampac-Fine-Chemicals-1 is seeking a Development Engineer III in Rancho Cordova, CA to lead complex process development and scale-up activities for APIs and intermediates, spanning lab, pilot, and early commercial manufacturing.

You will drive technical solutions with strong engineering judgment, collaborate cross-functionally, and contribute to commercial readiness and continuous improvement initiatives while ensuring compliance with GMP standards.

Qualifications

• Bachelor's degree in Chemical Engineering is required.
• 6-9 years of related experience, or 4-7 years with a Master's, or 1-4 years with a PhD in a related field.

Responsibilities

• Lead design and execution of laboratory and pilot-scale experiments for reactions, extractions, distillations, crystallizations, filtrations, and drying operations.
• Develop and reconcile scalable mass and energy balances through commercial projection; validate assumptions with plant data.
• Identify and implement process optimization strategies to improve yield, safety, robustness, and cycle time.
• Serve as technical lead for assigned projects and provide clear process recommendations to stakeholders.
• Own preparation and technical review of batch records, process descriptions, and first-scale batch documentation.
• Lead plant trials, demonstration campaigns, and first commercial batches; confirm CPPs, CQAs, and operating ranges.
• Troubleshoot scale-dependent issues and implement corrective actions during manufacturing campaigns.
• Partner with Manufacturing, Quality, EHS, and Supply Chain to ensure safe, compliant, and efficient scale-up.
• Evaluate reactive and hazardous materials, recommend mitigation strategies, and support hazard assessments.
• Collaborate on solvent selection, cleaning strategies, and waste stream optimization.
• Support environmental permitting considerations and ensure adherence to GMP and company safety standards.
• Apply Quality by Design (QbD) principles, including design of experiments (DoE), definition of CPPs, and control strategy development.
• Analyze process data to support investigations, deviations, and continuous improvement initiatives.
• Prepare technical reports, scale-up summaries, and client-facing documentation as required.

Skills

Chemical engineering

Pilot/early commercial campaigns

Troubleshooting

GMP awareness

Cross-functional collaboration

Excel

Data analysis

Education

Bachelor's degree in Chemical Engineering

Tools

DoE

Excel

Job description

Ampac-Fine-Chemicals-1 is seeking a Development Engineer III in Rancho Cordova, CA to lead complex process development and scale-up activities for APIs and intermediates, spanning lab, pilot, and early commercial manufacturing.

You will drive technical solutions with strong engineering judgment, collaborate cross-functionally, and contribute to commercial readiness and continuous improvement initiatives while ensuring compliance with GMP standards.