SREE RAMBABU JOGA Ph.D

• Process Development of API Generics for Regulatory Markets
• Developing a cost effective, plant feasible and ecofriendly process for Active Pharmaceutical Ingredients
• Designing and establishing alternative routes and non-infringing processes for API Generic products
• Cost reduction and continuous process improvement of the existing processes and Impurity profile study
• Support for DMF filing and addressing deficiencies
• Vendor qualifications and vendor development
• Process robustness studies through DOE studies
• Technology transfer to plant, support for trial and validation batches execution and plant troubleshooting
• Keen communicator with honed interpersonal, problem solving and analytical abilities.

• Established First R&D center in ASEAN region (Malaysia)
• Selected CMOs for project-specific activities
• Successfully developed and Tech Transferred First to File Non Onco API to China
• Process research and development of Onco generic APIs
• Leading the work of scaling up developments in the R&D
• Heading a team of 4-6 scientists including synthetic and analytical, projects
• Small scale (gm- Kg) production of APIs according to cGLP and cGMP requirements set in DMFs, controlled and approved by FDA
• Active role in Plant set up Oncology APIs products is under progress concept designs
• Product Selection and Portfolio Management in creating a product pipeline for future development
• Collaboration work with Business development team and Project management team for customer's new product proposals
• Patent reading and analysis and discuss with IPM team (Infringement analysis, search for novelty and prior art, assigning patentability) of APIs and Intermediates
• Cross-functional support to formulation development and other departments (Analytical, IP)
• To evaluate ROS of KSM and intermediates for Genotoxic impurities with software like Saraha nexus
• Impurity profiling including identification, isolation, degradation and characterization
• Assigning specification for API and its intermediates based on Purge and fate impurity study
• Preparing necessary documentation for DMF, Development report and Technology Transfer Document (TTD).

• Heading and guiding product developmental strategies to R&D teams
• Responsible for Business Development of API's/intermediates.

• Heading a team of 10 scientists from R&D
• Process Development of anti-retroviral, anti-diabetic, Anti glaucoma, nutraceuticals
• API molecules and technology transfer of the same
• Also preparing necessary documentation for DMF, Development report and Technology Transfer Document (TTD)
• Process improvement for cost reduction and easy technology transfer
• Facilitate the smooth and effective flow of resources between departments like R&D, QA, QC, and RA
• Having experience in supporting audits like USFDA, WHO and TGA and supported for couple of products.

• Heading a team of 25 chemists from R&D and analytical
• Laboratory experimental design, project planning and execution, team player
• Scale up and Development of Dl amino acids, Boc, Cbz, fmoc, new peptide intermediates (protected) API molecules.

• Heading a team of 11 scientists from R&D
• Laboratory experimental design, project planning and execution, team player
• CRAMS experience in synthesis of library of molecules in gram/kilo scale
• Scale up and Development of onco and non-onco API molecules and technology transfer of the same
• Facilitate the smooth and effective flow of resources between departments like R&D, QA, QC, and RA
• Having experience in supporting audits like USFDA, WHO and TGA and supported for couple of products.

• Heading a team of 6 chemists from R&D
• Laboratory experimental design, project planning and execution, team player
• Scale up and Development of new antiretroviral, antihypertensive, anticonvulsant, anti-fungal API molecules and technology transfer of the same
• Process improvement for cost reduction and easy technology transfer
• Facilitate the smooth and effective flow of resources between departments like QA, QC, and RA
• Having experience in supporting audits like USFDA, WHO and TGA and supported for couple of products.

• Heading a team of 12 chemists from R&D and analytical
• Laboratory experimental design, project planning and execution, team player.
• Scale up and Development of advanced intermediates, fine chemicals, specialty chemicals. new peptide intermediates(protected) for API molecules

Laboratory experimental planning and execution, team member.

Scale up and Development of new antipsychotic, antifungal, ant-histamine, antiemetic, antiretroviral API molecules and technology transfer of the same