MSAT Drug Product Owner

We are seeking a MSAT Drug Product Owner to provide technical support to our Drug Product portfolio, including Solid Oral Dose, Liquids, Creams, Ointments, and Sterile products.

The successful candidate will work closely with cross-functional teams to ensure safe, compliant, and efficient product operations. This will involve managing all technical aspects of the product and product family, including new product development, line extensions, product transfers, technology transfers, troubleshooting, continuous improvement initiatives, source changes, investigations, routine site support, and product lifecycle management (PLM) activities.

Key responsibilities:

• Provide technical support for development work, transfers, routine site support, improvement initiatives, source changes, material risk assessments (MRA), troubleshooting, and investigations
• Acquire and maintain product and process knowledge, effective product lifecycle management (PLM) with technical risk assessments (TRA), product control strategies (PCS), and continued process verification (CPV)
• Monitor product performance using statistical and digital tools, and develop risk assessments and mitigation plans
• Provide technical support for documentation, including MFR, MPR, SOP, PPR/APQR, change controls, and deviations
• Participate actively in validation activities
• Create presentations with technical data to support project and outcome approvals from local and global teams

Requirements:

• M. Pharm. (Pharmaceutics) or MS (Pharmaceutical sciences) with 3-12 years of experience, or Ph.D. with 2-7 years of experience in the pharmaceutical industry
• Experience with dose forms such as solid oral dose, liquids, creams, ointments, and sterile products
• In-depth knowledge and understanding of product dose forms and their manufacturing processes
• Knowledge of cGMP, regulatory requirements, QMS, statistical and digital tools
• Proven ability to work with cross-functional teams and drive projects
• Strong academic and industrial expertise
• Effective communication and leadership skills