Senior Process Development Engineer - Scale-Up

SK pharmteco; Rancho Cordova (CA); On-site; USD 130,000 - 200,000; Full time

Job summary

SK pharmteco is seeking a Development Engineer III to lead advanced process development for APIs and intermediates, spanning lab to pilot scale and early manufacturing. You will own process strategy, supervise DoE studies, and drive continuous improvement with cross-functional teams.

Based in Rancho Cordova, CA, the role requires strong technical judgment, GMP experience, and the ability to translate data into scalable manufacturing solutions. On-site work with safety and compliance focus.

Qualifications

• Bachelor's degree in Chemical Engineering required.
• Advanced degree in a related field is a plus and often preferred for senior roles.
• Experience leading scale-up and process development in chemical manufacturing.

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 DoE, 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.
• May perform other duties as assigned.

Skills

Mass and energy balances

Pilot-scale campaigns

Troubleshooting complex issues

GMP knowledge

Cross-functional collaboration

Excel proficiency

Education

Bachelor's degree in Chemical Engineering

Master's degree in related field

PhD in related field

Tools

Excel

Job description

SK pharmteco is seeking a Development Engineer III to lead advanced process development for APIs and intermediates, spanning lab to pilot scale and early manufacturing. You will own process strategy, supervise DoE studies, and drive continuous improvement with cross-functional teams.

Based in Rancho Cordova, CA, the role requires strong technical judgment, GMP experience, and the ability to translate data into scalable manufacturing solutions. On-site work with safety and compliance focus.