Role & responsibilities:
- Develop and optimize lyophilization cycles for PCR/qPCR reagents and controls.
- Design formulations using cryo/lyoprotectants for stable 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 workplace.
- 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.

Key Skills:
- Lyophilization process development
- Molecular reagent formulation
- DOE & statistical analysis
- GMP documentation & validation
- Process troubleshooting & scale-up
- Cross-functional collaboration

📌 Manager: Process (Bengaluru)
🏢 Bigtec
📍 Bengaluru