Senior Chemical Process Engineer – API Scale-Up & Transfer

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Paid Vacation

Job summary

Corden Pharma is seeking a Chemical Process Engineer to design and improve processes for complex small molecules, peptides, and highly actives for APIs. You will provide process engineering leadership, troubleshooting, and support for manufacturing and technology transfers.

The role requires a BS in Chemical Engineering with substantial experience in pharmaceutical manufacturing, a strong grasp of process development, scale-up, and regulatory standards within a GMP environment.

Qualifications

• BS in Chemical Engineering with 7 years of process engineering in pharma or fine chemicals.
• Ability to read and interpret scientific/technical documents.
• Strong problem-solving and project-management skills.

Responsibilities

• Scale up processes from kilo-scale to full production scale.
• Develop operating procedures, SOPs, PSI packages and process models.
• Lead technology transfers between manufacturing sites and implement scale-up tech.
• Perform process validation on API processes.
• Ensure compliance with FDA, cGMPs, EPA, OSHA, and PSM requirements.
• Identify and implement improvements to reduce costs and improve yield.

Skills

Process engineering

Scale-up

Technology transfer

Regulatory compliance

Education

BS in Chemical Engineering

Tools

Microsoft Excel

ChemE simulation software

Job description

Corden Pharma is seeking a Chemical Process Engineer to design and improve processes for complex small molecules, peptides, and highly actives for APIs. You will provide process engineering leadership, troubleshooting, and support for manufacturing and technology transfers.

The role requires a BS in Chemical Engineering with substantial experience in pharmaceutical manufacturing, a strong grasp of process development, scale-up, and regulatory standards within a GMP environment.