| || he Process Scientist (Purification) will support the manufacture of biologics bulk drug substance for commercial and late clinical phase products, through process understanding and applied science. He/She will provide technical support for purification manufacturing processes for clinical and commercial products (process monitoring, issue resolution, process improvements). He/She will be required to work in close collaboration with the Production Unit and Process Development to ensure quality, on-time supply of our products to our patients.
• Define needs for small/Pilot scale Purification studies supporting late stage development, major manufacturing changes/issues, or as required by regulatory commitments. Support execution planning, resourcing, and budgeting.
• Support technical oversight by MS&T Purification team of manufacturing unit operations. Review process data to ensure robust and reliable manufacturing performance and quality. Identify areas for improvement in process stability/variability or performance.
• Support troubleshooting of complex issues during purification manufacturing unit operations through process understanding and applied science and engineering. Support/Lead investigation teams, taking into account production environment constraints (e.g., business continuity, planning). Ensure good collaboration with other functions, and clear communication on progress and issues.
• Present technical analytical data clearly and concisely to customers.
• Support purification activities for process site transfers (gap/risk assessments, control strategy adaptation, transfer acceptance criteria). Support Purification Transfer team, including partners from different manufacturing sites (internal/external) and global functions.
• Review technical publications to stay abreast of technical developments in industry.
• Identify areas for introduction and development of innovative purification processing technologies.
• Support MS&T Purification team during regulatory and routine compliance audits/inspections.