SENIOR MANAGER - USP & DSP - R&D

• Planning execution of scale up scale down experiment for downstream process of any new vaccine and experience in technology transfer to GMP manufacturing.
• Planning, supervision execution of USP and DSP development for bacterial vaccine, polysaccharides, toxoids, recombinant protein (expresses in mammalian cells, yeast and bacteria).
• To ensure timely completion of all the projects assigned, experiment design, planning and execution of experiments.
• To develop robust purification process and optimization of process to obtain high yield quality product.
• Literature search scientific presentation and new strategy implementation for new product development.
• Basic knowledge on running fermentation process and managing fermentation activities.
• Co-ordination with Production department for technology transfer of the USP and DSP process.
• To provide support to the production department for any troubleshoot during production process.
• Co-ordination with warehouse / QA / QC / RA / HR / Administration /Global sourcing and maintenance department for the smoother functioning of R D activities.
• Proper training and enhance the overall capabilities of subordinates.
• Prioritization of tasks and completion of those in a timely manner.
• Review and Document preparation of SOPs, BR and Technology transfer and training to subordinates.
• Good understanding of working in GMP environment.
• Expertise and experience in trouble shooting in RD, supporting investigation of failures and trouble shooting in production.
• Familiarity with failure investigation and correction process in the GMP setting.
• Any other responsibilities as assigned by RD Head.

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