Qualification:

MSc with 15yrs+ or PhD with 12yrs+ ofexperience in DSP process planning, process optimization, development includingtroubleshooting supervision of activities related to Bacterial vaccineproduction. Industrial experience of 10 years or more is preferable.

Expertise:

USP and DSP development for bacterialvaccine, polysaccharides, toxoids, recombinant protein (expresses in mammalian cells,yeast and bacteria).

JOB RESPONSIBILITIES:
Planning execution of scale up scale down experiment for downstream process of any recent 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 recent 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.
Positive 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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📌 Senior Manager Usp & Dsp R&d Amritsar (India)
🏢 Panacea Biotec
📍 India