Develop and optimize lyophilization cycles for PCR/qPCR reagents and controls.
Design formulations using cryo/lyoprotectants for secure dry reagent systems.
Define and control Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using DOE and statistical tools.
Scale processes from R&D; to pilot and manufacturing batches.
Lead IQ/OQ/PQ and process validation activities for reagent and lyophilization processes.
Conduct stability studies, residual moisture analysis, reconstitution testing, and performance trending.
Prepare technical documentation including SOPs, BMRs, validation reports, and process development reports.
Support Design Transfer and collaborate with R&D;, QA/RA, Manufacturing, and Supply Chain teams.
Train manufacturing teams on lyophilization process controls and troubleshooting.





Preferred candidate profile:
Masters degree in Chemistry, Biochemistry, Biotechnology, Molecular Biology, or related field; PhD preferred.
5+ years of experience in molecular diagnostic reagent/process development.
Minimum 2 years of hands-on lyophilization development experience in GMP/IVD environment.
Strong expertise in PCR/qPCR chemistry, reagent stabilization, DOE, and process scale-up.
Experience with thermal characterization, Karl Fischer moisture analysis, stability studies, and lyophilizer qualification.
Working knowledge of ISO 13485, ISO 14971, ISO 20395, and CLSI EP guidelines.

📌 Lyophilization Expert (Bengaluru)
🏢 bigtec Private
📍 Bengaluru