Job Description

Job Summary
We are seeking a skilled professional to serve as a specialist in upstream/downstream operations, specializing in processes like mammalian cell culture, perfusion technology, scale-up, single use technology, Bioreactor characterization, Chromatography, Ultrafiltration, and Virus Filtration. The role involves authoring validation protocols, conducting risk assessments, utilizing tools for process verification, and actively participating in technology transfers to ensure compliant, productive, and continuously improved manufacturing processes.

Roles & Responsibilities

• You will serve as a Subject Matter Expert (SME) and actively engage in hands-on operations involving processes like cell culture, tech-transfer from lab to manufacturing scale, Chromatography, Ultrafiltration, TFF, Virus Filtration, and handling drug substance.
• Your responsibilities include authoring process validation protocols and reports, conducting risk assessments,



utilizing tools like Continued Process Verification (CPV), PAT Tools, and statistical analysis tools (e.g., JMP).
• You will be responsible for generating various documents related to process monitoring, investigating incidents for Deviations, and working with Quality Management Systems (QMS).
• Your role also involves active participation in technology transfers and implementing upstream/downstream processes including facility fit modelling based on process needs.
• You will build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.
• You will be responsible for ensuring compliance, control, cost-effectiveness, and continuous improvement of manufacturing processes.

📌 MSAT Specialist - Upstream (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad