Hanmanth Rao L

(Company Overview: A Dr. Reddy's Subsidiary.)

• Overseeing NCE scale-up from R&D to commercial production at multiple CDMOs, aligning with business strategy and market needs via IP or NIP patent pathways.
• Conducting process optimization, cost reduction, and stage-wise characterization to support robust process development.
• Identifying impurities and performing purification using techniques such as recrystallization, trituration, normal-phase chromatography, and reverse-phase chromatography, followed by characterization via LC-MS, NMR, and HPLC.
• Implemented cost-effective process development strategies, including solvent recovery, waste minimization, capacity enhancements, and raw material optimization.
• Identifying and addressing process safety hazards through HAZOP, risk assessments, thermal analysis, and RC1e experiments to ensure safety and scalability in NCE and API manufacturing.
• Reviewing batch manufacturing records, technical reports, change controls, and deviations from external vendors.
• Managing deviations, non-conformances, OOS/OOT, CAPA, and change controls to ensure compliance, and drive continuous improvement.
• Designed and executed DOE experiments, what-if studies, and stability studies to mitigate risks and prevent failures in plant-scale batches.
• Led process development, optimization, and validation of new drugs and intermediates, while managing a team of 2-3 chemists.
• Actively participating in teleconferences and meetings, and presenting project progress to senior management.

(Company Overview: A GVKBIO Company.)

• Job responsibilities included handling of FFS, CRAMS, scale-up of R&D batches, multi-step synthesis, and process optimization.
• Performed stage-wise characterization, impurity identification, preparation, process development, lab validation, and commercialization as per pre-defined business strategies and market demands through infringing patent routes (IP) or non-infringing patent routes (NIP).
• Characterized organic compounds using spectroscopic techniques such as NMR, LC-MS, HPLC, and GC.
• Coordinated with QA, RA, production, and QC for the technology transfer of a robust process to the kilo lab and plant-scale commercial production.
• Implemented effective cost controls on process development by applying recovery and reuse, wealth-from-waste strategies, capacity enhancements, and performance optimization for commercial volumes of raw materials.
• Successfully carried out the synthesis of different organic compounds by using different column chromatography (normal phase and reverse phase using a Combi-Flash instrument), crystallization, and high vacuum distillation techniques.
• Responsible for conducting laboratory-scale process hazard evaluations (process safety, risk assessment and management, process hazard analysis, HAZOP, etc.). Using thermal analysis, RC1e experiments, and other analytical techniques in support of the deployment of processes for the preparation of NCEs and APIs.
• Prepared optimization reports, consistency batch reports, and process development reports.
• Participated in weekly, biweekly, and monthly review meetings to share project programs with higher management and clients.
• Participated in a teleconference with customers, along with functional technical leaders.
• Responsible for improving workplace productivity, quality, GMP, safety, HAZOP studies, housekeeping, training the personnel, waste minimization, etc.
• Involved in managing deviation/non-conformance management, OOS/OOT management, CAPA, and change control, etc.
• Worked in coordination with cross-functional teams like MSAT, ARD, Engineering, Project Management, Manufacturing, QA, and QC departments.
• Identified possibilities for solvent recovery and establishment of the usage of recovered solvents in the process.
• Planned DOE experiments, what-if studies, and stability studies to avoid failures in plant batches.
• Lead the process development, optimization, and validation of new drugs and intermediates while managing a team of 4-5 chemists with the help of a manager.

• Executed the in-depth and detailed literature search and survey for existing or proposed drug molecules, or for a given task, as per business demands.
• Characterization of organic compounds using spectroscopic techniques such as NMR, LC/GC-MS, HPLC, and GC.
• Handled individual projects, involved in problem-solving, expert in purifications, plant support, and updates, participating in weekly, biweekly, and monthly review meetings to share project programs with higher management and clients.

(Company Overview: Now Aragen Life Sciences.)

• Involved in process optimization, what-if studies, and stability studies, Three consistently generates batch reports for the preparation of technical reports.
• Characterized organic compounds using spectroscopic techniques such as NMR, LC-MS, HPLC, and GC.
• Handled individual projects, was involved in problem solving, specialized in purification techniques, and ensured timely updates and deliverables.
• Engaged in a teleconference with customers, along with the functional technical team, to address project requirements and deliverables.

• Performed reactions, column purifications, literature searches, and prepared weekly updates.

• Involved in column purifications, prepared dry solvent, and planned reactions.