VAMSHI ATUKURI

Selection of API source, Excipients, Equipment's and packing materials.
Pre formulation studies.
Finalization of stable formulation process.
Initialization and review of stability studies as per ICH Guidelines and
requirements.
Finalizing the MFR [master formula record] and specifications.
Preparation of PDP(Product development process) and PDR( product
development record) by using QbD as per regulatory requirements.
Execution of Exhibit /Submission batches and optimization/Scale up batches
on plant Level.
FBD · Spray Drying · Hot melt extrusion · Wurster process · Top spray
granulation · Rapid mixture granulation

Conduct literature search to support formulation development
• Design and execute formulation development experiments leading to the development of patent
non-infringing and/or bioequivalent products (Immediate-release, controlled-release and sustain-
release oral dosage form).
• Evaluate process and formulation variables to develop a robust formulation.
• Compile routine analysis data, analyze and interpret the stability, polymorphism, residual solvent, and
dissolution data.
• Execute Scale-up and technology transfer process at Manufacturing Plant
• Prepare MFR, Pharmaceutical Equivalence Report ,Product Development Report (PDR), and other
necessary documents to support ANDA filing.
• Develop process for tablet manufacturing employing a variety of pharmaceutical manufacturing
techniques include high shear and low shear granulation, roller compaction and Fluidized bed
granulation, compression, coating, laser drilling, imprinting.
• Work related to formulating OROS Technology based monolayer ,bilayer tablets.
• Work related to formulating Hydrophilic Matrix tablets.
• Prepare pivotal batches for clinical studies.
• Execute multiple R&D Projects at fast-pace as per the organization’s timelines.
• Execute Pivotal, Pilot and ANDA batches with reference to the QbD and guidelines provided by the FDA

Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures
Maintain accurate record of analysis and perform documentation to company standards
Prepare test solutions, volumetric solutions, and samples used in analysis
Performs assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products analysis in an FDA regulated lab environment
Uses a variety of analytical instruments such as HPLC, Dissolution, Malvern, IR, Auto Titrator, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer etc.
Perform analysis with a practical understanding of the test procedure and instrument operation
Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results

Collects and records study data. Inputs all information into database
Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
Assists in preparing grant applications, IRB/GCO for submission and filings.
Maintains source documents and subject files in accordance with hospital procedures. Ensures accurate and complete compilation of subject data through chart reviews.