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Bengaluru, Karnataka, India
Onsite
Not Available
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an MSAT Drug Product Owner based in India.
As an MSAT Drug Product Owner, you will provide technical leadership and expertise across a diverse pharmaceutical product portfolio, including solid oral dosage forms, liquids, creams, ointments, and sterile products. You will oversee critical technical activities throughout the product lifecycle, from new product development and technology transfers to routine manufacturing support and continuous improvement. Working closely with cross-functional teams, you will help ensure safe, compliant, and efficient manufacturing operations. You will also drive technical risk assessments, product performance monitoring, investigations, and process optimization initiatives. This role offers the opportunity to influence product quality, manufacturing reliability, and operational excellence within a science-driven pharmaceutical environment. You will collaborate with local and global stakeholders to deliver robust technical solutions and support the successful lifecycle management of pharmaceutical products.
You will take ownership of the technical aspects of assigned drug products and product families, ensuring effective lifecycle management and providing expert support across development, manufacturing, and transfer activities. Through collaboration with cross-functional teams, you will drive technical improvements, maintain regulatory compliance, and support consistent product quality and operational performance.
Provide technical support for new product development, product transfers, technology transfers, routine manufacturing operations, and continuous improvement initiatives.
Support source changes, material risk assessments (MRA), troubleshooting activities, and technical investigations.
Develop and maintain comprehensive product and process knowledge across solid oral dosage forms, liquids, creams, ointments, and sterile products.
Drive Product Lifecycle Management (PLM) activities, including Technical Risk Assessments (TRA), Product Control Strategies (PCS), and Continued Process Verification (CPV).
Monitor product and process performance using statistical methods and digital tools to identify trends, assess potential risks, and recommend improvements.
Develop and implement risk assessments and mitigation plans to address manufacturing, quality, and process-related challenges.
Provide technical input and support for essential documentation, including Master Formula Records (MFR), Master Production Records (MPR), Standard Operating Procedures (SOPs), Product Quality Reviews (PPR/APQR), change controls, and deviation reports.
Actively participate in validation activities to ensure processes and products meet established quality and regulatory requirements.
Prepare and deliver technical presentations supported by relevant data to obtain project approvals and communicate outcomes to local and global stakeholders.
Collaborate with multidisciplinary teams to drive projects, resolve technical issues, and ensure effective implementation of manufacturing improvements.
Requirements:
The ideal candidate is a pharmaceutical technical professional with strong expertise in drug product manufacturing, process development, and lifecycle management. You should combine scientific knowledge with practical industrial experience, demonstrating the ability to lead technical projects, assess risks, and work effectively with diverse stakeholders. Strong communication, analytical thinking, and data-driven decision-making skills are essential.
Education and experience:
Master's degree in Pharmacy (M. Pharm. – Pharmaceutics) or a Master's degree in Pharmaceutical Sciences, with 3–12 years of relevant pharmaceutical industry experience.
Alternatively, a Ph.D. with 2–7 years of experience in the pharmaceutical industry.
Professional experience with multiple pharmaceutical dosage forms, including solid oral dosage forms, liquids, creams, ointments, and sterile products.
In-depth understanding of pharmaceutical formulations, dosage forms, and associated manufacturing processes.
Strong knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and Quality Management Systems (QMS).
Experience in product lifecycle management, technology transfers, process validation, and continuous improvement activities.
Familiarity with statistical methods and digital tools for product performance monitoring and process optimization.
Ability to lead technical projects, coordinate cross-functional activities, and drive initiatives from development through implementation.
Strong scientific and industrial expertise, with the ability to provide technical guidance and support complex pharmaceutical projects.
Excellent communication, presentation, stakeholder management, and leadership skills.
Strong problem-solving abilities and a proactive, risk-aware approach to technical decision-making.
Familiarity with GxP regulations, data integrity principles, CMC strategy, and technology transfer practices.
Additional capabilities in project management, Lean management, process optimization, scientific writing, and data-driven decision-making are highly valued.
Benefits:
Full-time employment opportunity.
Remote working arrangement, with the position identified as a field-based role.
Opportunity to contribute to pharmaceutical product development and manufacturing excellence.
Exposure to a diverse portfolio of pharmaceutical dosage forms and complex technical projects.
Collaboration with cross-functional teams and international stakeholders.
Opportunities to develop technical expertise in product lifecycle management, technology transfers, and pharmaceutical manufacturing.
Inclusive and collaborative working environment that encourages professional growth and continuous learning.
Opportunity to contribute to initiatives focused on improving the quality, safety, and availability of healthcare products.
