R&D Formulations - Biologics/Liposomes/CDMO - Sr.Manager/AGM

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 new 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 execution.
• Support proposal preparation, project costing, scope definition, and resource planning for new CDMO opportunities.
• Mentor, train, and develop team members; support performance management and talent development initiatives.
• Ensure compliance with cGMP, GxP, data integrity, biosafety, quality systems, and client-specific requirements.
• Ensure availability, qualification, calibration, maintenance, and optimal utilization of laboratory and pilot-scale equipment.
• Review and approve SOPs, change controls, deviations, CAPAs, investigations, and other quality system documents.
• Maintain laboratory efficiency, resource planning, safety standards, housekeeping, and continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure successful delivery of client projects from development through commercial manufacturing.
• Perform any other responsibilities assigned by the Head of Department.