Job Description
Job Responsibility and key Decisions
Assist in the development, optimization, and scaleup of drug substance manufacturing processes, including fermentation, cell culture, and purification.
Support process characterization and performance assessments to ensure consistent product quality.
Collaborate with crossfunctional teams to troubleshoot and improve process efficiency and yield.
Conduct experiments, collect data, and analyze results to support process development and optimization.
Ensure compliance with GxP, SOPs, and regulatory requirements during all process activities.
Prepare and maintain detailed documentation for process development, validation, and regulatory submissions.
Assist in tech transfer activities and ensure smooth scaling of processes from laboratory to production scale.