Panacea Biotec - Senior Manager - Research & Development

JOB SUMMARY:

FLM USP and DSP development of vaccine candidates.

Support manufacturing (as part of manufacturing sciences group).

Qualification:

MSc with 15yrs+ or PhD with 12yrs+ of experience in DSP process planning, process optimization, development including troubleshooting & supervision of activities related to Bacterial vaccine production.

Industrial experience of 10 years or more is preferable.

Expertise:

- USP and DSP development for bacterial vaccine, 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 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 R&D, 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 R&D Head.