Role : Functional Lead - Upstream Processing
Location : Bangalore
Role in a Nutshell:
We are seeking an experienced Upstream Process Development professional to lead the development, scale-up, and characterization of cell culture processes for monoclonal antibodies (mAbs) and fusion proteins. The role offers the opportunity to work across multiple biologics programs, driving robust and scalable manufacturing processes from development through technology transfer and commercialization.
Why Join Us?
Be part of a high-impact biologics R&D; organization focused on advancing innovative therapies through cutting-edge process development, scientific excellence, and collaborative innovation.
Key Responsibilities:
- Lead upstream process development, optimization, scale-up, and process characterization activities for biologics programs.
- Design and execute experiments in shake flasks, Ambr® systems, and laboratory-scale bioreactors, with scale-up support up to pilot scale (50L and beyond).
- Develop scalable, robust, and efficient cell culture processes to meet product quality,



productivity, and commercialization targets.
- Apply Quality by Design (QbD), statistical tools, Design of Experiments (DOE), and risk assessment methodologies to support process development and technical decision-making.
- Collaborate closely with cross-functional teams including Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Program Management.
- Support technology transfer activities and ensure timely delivery of development milestones across multiple projects.
- Contribute to regulatory submissions, audits, inspections, and preparation of technical dossiers.
- Analyze experimental data and provide scientific insights to drive process improvements and development strategies.
- Ensure compliance with Valuable Documentation Practices (GDP), data integrity requirements, and regulatory expectations.
- Prepare technical reports, development protocols, presentations, and SOPs/IOPs

📌 Functional Lead (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru