The specialist is responsible for the daily execution and monitoring of manufacturing and supply plans for drug substances and finished goods. They act as a key coordinator to ensure reliable product availability by tracking supply status, managing orders, and resolving bottlenecks.
The Manager will oversee post-approval CMC regulatory filings, including variations and supplements, to ensure compliance with global health authorities. They will also evaluate CMC changes for regulatory impact and collaborate with cross-functional teams to maintain regulatory dossiers.
The Director will lead the modernization of clinical quality oversight and audit architecture while managing inspection intelligence frameworks. They are responsible for deploying risk-proportionate quality assurance tactics and leading a team of CMQ managers to ensure compliance across clinical programs.
The role involves reviewing and assessing analytical data, technical documentation, and method validation protocols for biological products. You will also collaborate with cross-functional teams to prepare scientific reports on product characterization, stability, and analytical similarity.
The role involves reviewing and assessing analytical data, authoring validation protocols, and preparing scientific reports for biological products. You will collaborate with laboratory scientists, Quality Assurance, and Regulatory Affairs to support product characterization and stability studies.
The Director will lead global commercial planning, forecasting, and supply allocation strategies for the biosimilars portfolio. They will also support business development by creating robust financial models and market-based forecasts for new opportunities.
The Director will lead and advance statistical and data management programming activities for biosimilar studies while ensuring high-quality, compliant deliverables. They will establish robust programming capabilities, standards, and processes while providing strategic leadership and mentoring to the team.
