Ranjan Raj

Planning and execution of experiments at shake flask and bioreactor scale.

Responsible for sub cloning and in fusion based cloning, transformation, screening and protein expression in Pichia pastoris, e.coli and insect cell.

Responsible for media optimization and clone selection.

Responsible for Report preparation and presentation to the client

· Strategic execution of commercial, clinical trial and R & D batch processing of Ranibizumab, GCSF, Romiplostim and PTH (from E-coli) to improve quality and yield of product.

· Planning and its execution for streamline operations of upstream batch processing.

· Execution of scaled up and validation batches as per designed process.

· Responsible for upstream Operation like preparation of seed and production fermentation, batch monitoring and trouble shooting.

· Online Documentation (Batch Manufacturing Record and Equipment Usage Records)

· Handling of Quality management tools (change control, deviation, incident etc.)

· Involved in validation & qualification of equipment and scale up activities.

· Preparation and primary characterization for cell banks.

· Planning of batch activity as per requirement and shift management.

Worked as Executive- Bacterial Vaccine production with Panacea biotec Ltd

Responsible for the consistent production of HIB type b and Bordetella pertussis strain 10536, 509 and 143.

· Experienced in working in cGMP environment.

· Responsible for upstream Operation like preparation of seed and production fermentation, batch monitoring and trouble shooting.

· Responsible for the preparation of master cell bank and working cell bank.

· Involved in validation & qualification of equipment and scale up activities

· Responsible for centrifugation microfiltration and ultrafiltration.

· Handling of Bioreactors/CIP systems, Centrifuge, Depth filtration

· Online Documentation (Batch Manufacturing Record and Equipment Usage Records)

· Handling of Quality management tools (change control, deviation, incident etc.)

Project handled:

Optimization and production of recombinant human serum albumin and lactase from pichia pastoris.

Description:

• Process development and optimization of physicochemical parameters in high cell density fermentation.

• Media optimization

• Involved in scale up studies

• In-process quality checks

• Microscopic studies

• Gel loading for protein profiling

• Sterility testing

• Shake flask studies for clone selection and to evaluate the nutrition parameters of amino

acids.Batch monitoring (medium preparation, inoculation, feeding, and termination.)

• Inoculum development and preparation of glycerol stock cell banks.

• Microfiltration and ultrafiltration of protein (10kda, 30kda, 0.5µ and 0.2µ).

• Dealt with the Process development and production of Penicillin G amylase from e.coli

• Responsible for Upstream Operation like preparation of seed and production fermentation, in process batch monitoring and trouble shooting.

• Handling of Bioreactors/CIP systems, Centrifuge, Depth filtration, media preparation,

• Documentation (Batch Record, Equipment Usage Records, and Daily Documents).