COMPANY: BE Biosol Private Ltd.

DEPARTMENT: Formulation R&D; (Biologics Development & CDMO Operations)

DESIGNATION: Senior Manager /Assistant General Manager
- Lead biologics product development activities, including formulation development, process development, and product lifecycle support and liposomal drug delivery system for CDMO clients.
- Design, plan, supervise, and monitor customer development projects to ensure achievement of technical, quality, cost, and timeline objectives.
- Act as the technical lead and primary scientific interface for client projects, supporting project discussions, technical reviews, and development strategy alignment.
- Review client requirements, product development plans, technology transfer packages, and project deliverables.
- Lead process optimization, scale-up, technology transfer, and process validation activities for clinical and commercial manufacturing.
- Support execution of engineering, exhibit, PPQ/process validation, and commercial batches in coordination with Manufacturing and Quality teams.
- Review and approve experimental data,



protocols, reports, laboratory records, technical documents, and development summaries.
- Review stability, characterization, and comparability study data and recommend further development activities.
- Provide scientific and technical support for client audits, regulatory inspections, due diligence activities, and customer meetings.
- Support preparation and review of CMC documentation, technology transfer documents, risk assessments, development reports, and regulatory submission packages.
- Provide scientific justification and responses to regulatory and client queries related to product, process, and manufacturing.
- Evaluate current business opportunities, feasibility assessments, development timelines, and project budgets to support CDMO business growth.
- Coordinate with clients, SCM, vendors, Manufacturing, QA, QC, Analytical Development, and Regulatory Affairs for seamless project exec

📌 R&D Formulations (Shamirpet)
🏢 Biological E
📍 Shamirpet