MSAT Drug Product Owner

About the role

GSK is hiring a Drug Product Owner (MSAT) based in Baddi, Himachal Pradesh, working remotely. The role provides technical support to the drug product portfolio covering solid oral doses, liquids, creams, ointments and sterile products, and works closely with cross-functional teams to keep product operations safe, compliant and efficient. It covers new product development, line extensions, product and technology transfers, troubleshooting, continuous improvement, source changes, investigations, routine site support and product lifecycle management.

Key responsibilities

• Provide technical support for development work, transfers, routine site support, improvement initiatives, source changes, material risk assessments, troubleshooting and investigations.
• Maintain product and process knowledge, including PLM, technical risk assessments, product control strategies and continued process verification.
• Monitor product performance using statistical and digital tools, and carry out risk assessments and mitigation plans.
• Support documentation such as MFR, MPR, SOP, PPR/APQR, change controls and deviations.
• Take part in validation activities and present technical data to local and global teams for project and outcome approval.

Required profile

• M.Pharm (Pharmaceutics) or MS in Pharmaceutical Sciences with 3 to 12 years of experience, or PhD with 2 to 7 years of pharmaceutical industry experience.
• Experience with dose forms such as solid oral doses, liquids, creams, ointments and sterile products, and in-depth knowledge of their manufacturing processes.
• Knowledge of cGMP, regulatory requirements and quality management systems.
• Proven ability to work with cross-functional teams and lead projects, with strong communication and leadership skills.

Required skills

• CMC strategy, data-driven decision making and data integrity
• GxP regulations and scientific writing
• Lean management, problem solving and process optimization
• Project leadership, risk awareness and technology transfer