About the role
Serán is seeking a hands-on Process Engineer with deep spray drying expertise to develop, scale, and transfer robust processes for small molecule and complex drug products. You will lead end-to-end unit operations—from feasibility and DOE through clinical/commercial scale-up—while ensuring safety, quality (GMP), and operational excellence in a fast-paced, collaborative environment.
As the system owner, the Process Engineer oversees creation and revision of equipment documentation packages, supports regulatory and client audits, and ensures alignment with cGMP expectations. They maintain a deep, data‑driven understanding of equipment performance, analyze trends to anticipate issues, and drive improvements that enhance reliability, yield, and product quality. The role collaborates closely with Maintenance, Quality, Validation, and Manufacturing to coordinate spare‑parts strategies, preventative maintenance, calibration schedules, and implementation of clean‑in‑place systems. In a CDMO setting, the engineer also partners with clients and internal teams to support tech transfers, scale‑up activities, and lifecycle management of spray‑drying processes.
Aplyr's read
Serán BioScience is a dynamic biotechnology firm innovating in diagnostics and therapeutics, attracting a diverse workforce from scientists to business developers.
What's promising
- •Strong focus on developing cutting-edge diagnostics and therapeutics.
- •Recent hiring across diverse roles indicates growth and expansion.
- •Opportunities for career advancement in a specialized biotech field.
What to watch
- •Biotechnology sector can be volatile and subject to regulatory changes.
- •Limited public information about financial stability and long-term viability.
- •Highly specialized roles may limit opportunities for generalists.
Why Serán BioScience
- •Specializes in both diagnostics and therapeutics, offering a broad scope of innovation.
- •Recent expansion into commercial manufacturing suggests strategic growth.
- •Emphasis on quality assurance highlights commitment to regulatory compliance.
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About Serán BioScience
Serán BioScience is a biotechnology company focused on developing innovative solutions for healthcare, particularly in the areas of diagnostics and therapeutics.
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