Key Responsibilities:
1. Downstream Process Development & Optimization
Unit Operations: Design, develop, and optimize robust purification processes including Protein A affinity capture, low pH viral inactivation, polishing chromatography (AEX, CEX and other chromatography modes), and Ultrafiltration/Diafiltration (UF/DF).
Column Operations: Conduct resin screening, load optimization, step-yield evaluations, and resin lifetime studies to maximize process efficiency.
Quality Attributes: Evaluate and control Critical Process Parameters (CPPs) to ensure consistent alignment with product Critical Quality Attributes (CQAs).

2. Process Characterization, Characterization & Scale-Up
Experimental Design: Design and execute Design of Experiments (DoE), robustness evaluation, and process characterization studies to establish operating spaces.
Scale-Up & Tech Transfer: Author tech transfer documentation, scale-up protocols, and process descriptions to support tech transfer to pilot plant and clinical/commercial GMP manufacturing.
Viral Safety: Plan, execute, and provide in office or remote support for Viral Clearance Studies (VCS), spanning low pH inactivation, nanofiltration, and chromatography step challenges.

3. Compliance, Documentation & Data Integrity




Good Documentation Practices: Maintain contemporaneous, accurate, and completely traceable laboratory notebooks and electronic records.
Data Integrity: Ensure total data integrity by adhering strictly to ALCOA+ principles, participating in rigorous data reviews, and ensuring audit trail compliance.
Regulatory Adherence: Author high-quality standard operating procedures (SOPs), technical reports, and protocol deviations in compliance with regulatory expectations and internal guidelines.

Required Technical Skills:
Chromatography Systems: Comprehensive hands-on proficiency with KTA chromatography systems (e.g., Avant, Pure, Pilot) and Unicorn software control.

Filtration Systems: Direct operational knowledge of Tangential Flow Filtration (TFF/UFDF) systems utilizing both cassette and hollow fiber configurations.

Regulatory Frameworks: Sound technical understanding of viral clearance validation strategies and regulatory expectations outlined in ICH Q5A.

In-Process Analytics: Working knowledge of basic biophysical/biochemical analytical techniques used to monitor purification outputs (e.g., Analytical SEC, Analytical CEX, and quantitative Protein A analysis).

📌 Downstream Process Development (Karnataka)
🏢 Aragen Life Sciences
📍 Karnataka