Position Details
About this role
This role involves leading process engineering efforts in a GMP manufacturing setting, focusing on process robustness, scale-up, and continuous improvement for drug product manufacturing.
Key Responsibilities
- Lead process development
- Ensure GMP compliance
- Perform process robustness assessments
- Manage deviations and change controls
- Support scale-up activities
Technical Overview
Expertise in GMP processes, process development, Design of Experiments, Quality by Design, and process validation. Experience with small-molecule manufacturing is preferred.
Ideal Candidate
The ideal candidate is a process engineer with 5+ years of experience in GMP manufacturing and process development, skilled in process robustness, root cause analysis, and scale-up activities for drug products.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of GMP manufacturing experience, No experience with process validation or scale-up, No familiarity with GMP documentation, Unwilling to work in a hybrid environment
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