Senior Executive R&D Quality CMC QA

About the role

To provide independent quality review and oversight of CMC development and technology transfer activities, ensuring that development data, processes, and documentation are compliant, scientifically robust, and fit for technology transfer, regulatory submissions and commercial manufacturing readiness .

What you'll do

• Provide quality oversight for Chemistry, Manufacturing & Controls (CMC) activities within Biotech R&D to ensure compliance with global internal quality standards and…
• Review and approve CMC development documents, including Product Development Reports, Process Development Reports, Product Quality Risk Assessments
• Conduct independent quality review of upstream and downstream process development data to ensure scientific integrity, completeness, traceability
• Support technology transfer process by performing quality review and approval of technology transfer protocols, reports, batch records, comparability assessments
• Ensure data generated during development, scale-up, engineering and submission batches are accurate, complete

What you need

• 8–10 yrs of experience
• Regulatory affairs
• GMP
• SOP writing
• Chemistry
• M.Tech or M.Sc