Ashwin Venkatakrishnan

Experience

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  Solara Active Pharma Sciences

  Jul 2018 - Aug 2018

  Synthetic Chemistry R&D Intern

  • Explored research articles on different pathways for synthesis of Active Pharmaceutical Ingredients (APIs).• Corresponded with associate lab scientists and lab managers to determine the best pathway for synthesis.• Conducted chemical reactions at a GMP-compliant laboratory to observe and record the formation of API.• Tracked reaction conditions and performed timely analysis of reactions using Thin Layer Chromatography (TLC).

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  BASF

  Jul 2019 - Aug 2019

  Plant Operations Intern

  • Collaborated with plant heads and several plant engineers to compile a report of operations at 4 manufacturing facilities including dispersions, dyes, construction chemicals, and coatings. • Presented findings of report to a panel of senior chemical engineering faculty members from BMS College of Engineering.

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  B. M. S. College of Engineering

  Feb 2021 - May 2021

  Project Assistant

  • Investigated, tested, and reviewed routes to synthesize Sodium and Potassium Stannate from Tin (IV) Oxide waste generated by an Active Pharmaceutical Ingredients (APIs) manufacturing facility.• Engaged and communicated with several administrative and technical personnel for expertise, authorizations, and mentorship.• Developed a scheme to synthesize commercial-grade Sodium and Potassium Stannate.

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  Bayer

  Jan 2022 - Aug 2022

  Tech Transfer and Process Development R&D Co-op

  • Engaged in developing robust manufacturing processes for new pharmaceutical products and transferring them from laboratory scale to pilot plants and manufacturing sites. Aligned cross-functionally with Formulation Scientists, Analytical Chemists, and GMP Operations, to ensure seamless development and manufacture of products at different stages in pipeline.• Manufactured pilot scale campaign batches of new products in GMP environment, and packaged the products for clinical trials and experimental purposes. Employed Corrective and Preventive Actions (CAPA’s) to ensure GMP conformance.• Generated Reports for manufactured product registration batches containing critical process parameters, in-process test data, and drug release data for compressed and packaged tablets.• Designed and executed laboratory experiments to analyze and optimize the flow behaviour of drug products by performing Powder Rheometry, Particle Size Distribution, and Bulk and Tap Density analyses. • Generated and maintained a database of powder flow properties across drug substances to facilitate early detection of process scale-up issues like segregation, agglomeration, and attrition within solid dosage formulations. • Researched and investigated the incorporation of computational flow simulation to expedite Scale-up and technology transfer of liquid products. Utilized Computational Fluid Dynamics (CFD) to model and characterize fluid flow within 3 agitated vessels of increasing batch sizes. Performed shear and mixing analyses to track formation of product and enhance mixing efficiency at each batch size.• Authored and designed new templates for Batch Process Records of Tablet Compression and Coating Processes.• Reviewed and Transferred Standard Operating Procedure (SOP) documents from previous to new formats.• Created Excel tools that perform automatic algorithm-based calculations to facilitate efficient Cleaning Validation decision making. Show less

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  Purdue University

  Aug 2022 - May 2023

  Graduate Student Researcher

  • Headed the implementation of an open-source Thermal Hazard Analysis web tool which accurately estimates the Heat of Reaction of 2500+ chemical substances. • Defined weekly goals over a 5-month period with detailed actionable steps and delegated responsibilities as needed. Communicated with several stakeholders to ensure smooth execution of steps.• Conducted extensive literature search of 6 non-centralized thermodynamic data sources and consolidated data into one master database.• Built a backend algorithm on python for performing Heat of Reaction estimation and collaborated with frontend developer to build the user interface for the web tool. • Delivered the first version within specified 5-month timeframe and developed a validation and maintenance protocol for the tool. Show less

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  Bend Bioscience

  Jun 2023 - now

  Drug Product Formulation and Process Engineer

  • Designing experiments and research plans to develop new and/or improve drug product processes for pharmaceutical formulations.• Being a subject matter expert on key unit operations including but not limited to blending, dry granulation, tableting, and film coating. • Utilizing risk assessments to effectively communicate and plan future studies relative to drug product formulations and processes. • Understanding and designing experiments to challenge the effect of process parameters on quality attributes. Including but not limited to design of experiments and one factor at a time workplans. • Developing and implementing operational systems, protocols, procedures, and work instructions focused on process equipment and/or facility operations.• Assisting operations in batch record drafting, approval, execution and/or review when required with a focus on technical and operational leadership.• Collaborating with clients and suppliers on operational requirements to successfully manufacture clinical batches. Show less