Sai Ram Reddy Puchakayala

Experienced chemical engineer with over 11 years of experience in pharmaceutical API and CDMO. Holds a Master's in Chemical Engineering from JNTU Hyderabad and an MBA in Manufacturing Management from BITS Pilani & Certified Process safety professional. Proven expertise in diverse technical roles, including technology transfer, technical services, plant process engineering, and operational excellence. Deep knowledge of process safety management, ensuring efficient and compliant operations. Skilled in capacity enhancement, Cost improvement initiatives, time cycle reduction, and debottlenecking. Having knowledge in creating facilities for handling high-potent molecules and implementing process optimization strategies based on potent molecule handling.Dedicated to driving excellence in pharmaceutical manufacturing through innovative solutions and strategic leadership.

• Reviewing of facility & overall capacity enhancement of all commercial products based on the business requirement.
• Modification of Existing oncology blocks to have proper containment philosophy across the facility.
• Creation of new oncology kilo-lab for manufacturing of OEB-5 category molecules.
• Executed the scale-up batches of Ozonolysis reaction in plant scale by taking the necessary safety precautions based on the process safety data & by using DynoChem in Estimating the agitator geometry & RPM.
• Worked on commercialization of Nano filtration technology for concentration of reaction mass in API stage of peptide molecule due to its sensitivity towards higher temperature.
• Designing of continuous gravity flow decanter for separating water from toluene, it has reduced the batch time cycle from 52 hours to 15 hours.
• Installation of ATFD for Leveteracetum which has completely reduced the contamination of Acetone with MDC by which the recovery batches and purification batches are also completely avoided.

• Assistant Manager, Viatris R&D Centre, IDA, Bollaram, Medak Dist, 08/01/15, 03/01/22
• Assistant Manager, DR Reddy’s Laboratories Ltd, IDA, Bollaram, Medak Dist, 09/01/14, 08/01/15
• Engineer, Hetero labs ltd, Hyderabad, 07/01/12, 09/01/14

• Facility creation for Cytotoxic product handling facility up to OEB-5 classification.
• Process safety management coordinator for ~ 4 Manufacturing sites & 2 R&D centers.
• Executed the scale-up batches of a critical product with OZONOLYSIS reaction at plant scale with 2kg/hr ozone generator.
• Worked on scale-up of Iron Molecules from lab scale to pilot & plant scale.
• Implemented NANO filtration technology & other Tangential flow filtrations at lab scale & at plant scale for concentration of reaction mass in the Pharma step of peptide molecule, which is highly sensitive towards heat.
• Implementation of commercial scale ion exchange process by using Ion exchange resin and Glass column.
• Performed process robustness study for a commercial product and implemented most of the critical output of the study
• Designing of continuous gravity flow decanter for separating water from toluene in Azeotropic distillation.
• Installation of New Technology process equipment & Handling it for validation batches in production blocks for various products.
• Calculating SRV and Rupture disc based on reactor capacity and solvents used in it.
• Designing of distillation column for methanol and acetone mixture.
• Facility modification proposals for effective utilization of resources & working on cost improvement initiatives.
• Trouble shooting of multiple effect evaporators to increase its efficiency.

• Oversee of Technology transfer & Technical Services Teams.
• Responsible for Technology transfer of new products from Lab scale to plant scale.
• Coordination with CFT for facility readiness & project planning for effective utilization of available resources.
• Review of Equipment mapping & R&D process and providing technical input on safety & design of process & process equipment.
• Chemical engineering expertise and input on safety, design, troubleshooting, scale-up, equipment Selection, optimization, cost reduction and technology transfer of API processes.
• Guiding the team in usage of simulation software like DynoChem for Critical requirements such as reactor and agitator geometry details and estimating the required RPM for executing the validation batches in plant.
• Review of Selection, Mapping of equipment's and calculations w.r.t to the utility requirement and safe addition time for Exothermic reactions.
• Coordination with CFT & preparation of Gantt chart for all the critical events in the project timelines to ensure timely completion of project.
• Technical support in process design of cytotoxic products to ensure minimum exposure to operators.
• New Facility creation w.r.t to product categories up to OEB-5 with proper containment philosophy.
• Scale up of API products from Laboratory to Kilo Lab, Kilo Lab to Pilot Plant, Pilot Plant to plant (ensuring smooth Scale-Up from Lab to Plant).
• Reviewing the Process & powder safety data (i.e reaction calorimetry, ARSST, TSU, & MIE) to do the calculations which are required for safe execution of batch in plant scale.
• Reviewing the Design calculations of heat transfer equipment to ensure the suitability of the equipment for the required process.
• Reviewing of supporting document for Development report which consists of safety risk assessment along with MOC compatibility, Material Balance, corrosion/coupon study for selection of MOC, Effluent generation along with analysis for kg of product.
• Reviewing of experimental data which are performed in lab cylindrical vessels based on the available equipment’s in plant by doing scale-down calculations.

NEBOSH-Process safety management