JOB DESCRIPTION

Job Title: SME USP MSAT

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines
- End-to-end MSAT ownership of upstream processes from cell line handover through technology transfer, validation, comparability, and commercial lifecycle management.
- Process scale-up/scale-down, characterization, and execution of Continued Process Verification (CPV).
- Documentation: Author/review BMRs, MBRs, SOPs, risk assessments, comparability protocols, and technical reports.
- Manufacturing support:



Provide on-floor support, troubleshooting, and deviation investigations.
- Performance monitoring: Lead process monitoring, trending, and data analysis.
- Validation strategies: Design and execute Stage 1–3 process validation.
- Regulatory support: Contribute to IND/BLA/MAA filings and respond to health authority queries.
- Statistical expertise: Apply DoE, multivariate analysis, regression modeling, and advanced statistical tools in process monitoring, troubleshooting, characterization etc.
- Process characterization: Drive studies for design space development and CPP identification.
- Risk management: Lead structured risk assessments (FMEA, HACCP, risk ranking) and mitigation strategies.
- QbD principles: Define control strategies and ensure robust process design.
- Deviation/CAPA ownership: Lead root cause investigations, CAPA, and change control.
- Cross-functional collaboration: Interface with PD, QA, QC,

📌 Sme Usp Msat (Bengaluru)
🏢 Syngene
📍 Bengaluru