Laxman Rao.V

Pharmaceutical professional with a Master’s in Pharmacy, skilled in applying innovative solutions to enhance organizational efficiency. Proven track record of commitment to quality and excellence in task execution. Strong ability to adapt and contribute to team success while pursuing continuous professional development.

• M.Pharm, 2013, 72%, Vikas college of pharmacy (JNTUH)
• B.Pharm, 2011, 66%, RME’S College of pharmacy (RGUHS)
• Intermediate, 2007, 82%, Sri chaitanya junior college (Board of intermediate) AP
• SSC, 2005, 82%, Shivani high school (Board of Secondary Education) AP

Literature search and review including patents, Preparation of Master Formula Card, Protocols & Pharmaceutical Development Report for various Regulatory markets, Preparation of Pharmaceutical Development Report as per Qbd with the application of design of experiments for US market, Identifying CQA’s and establishing QTPP for drug product, Ability to carry out risk assessment to identify the impact of Critical process parameters and Critical material attributes on Critical quality attributes at different stage of product development, Development & optimization of products with API and Excipients/Raw materials sourced from alternate vendors, Expertise in designing Process mapping and sampling plan for trial, Scale up and batches of various solid oral dosage forms, Involved in preparation, Review and Recommendations for Process Optimization Report and Deficiency response for all geography markets within the stipulated timeline, Working along with formulation development team for technology transfer of Robust and scalable product from development to pivotal stage, In depth knowledge of application of scientific and process engineering principles to develop process understanding and scale up of product from laboratory to commercial scale, Participate in technical assessment coordination to mitigate anticipated and unexpected risks associated with NPLs through a precautionary approach, Expertise in manufacturing process improvements through data analysis, identification of critical process parameters and their attributes, Ability to carry out risk assessment to identify the impact of Critical process parameters and Critical material attributes on Critical quality attributes at different stage of product development, Knowledge on the processes such as Granulation, Mixing, Solid dosage, Scale-up, Technology Transfer, Continued Process Verification, Process Development, Involved in execution of project tasks per given timelines, including technology transfer process for New Products Introduction, Products Improvements, and new API /Raw material qualification, Knowledge and understanding of quality by design, equipment design, cleaning procedures development, analytical methods, sampling requirements, and in the collection and evaluation of data, Involved in conducting investigations related to product out of specification or process deviation, stability deviation, consumer market complaints, and other investigations as per requirements, Expertise in using scientific principles to resolve moderately sophisticated technical challenges while being able to articulate complex subject matter in clear, concise terms as process scientist, Manage new product launches (NPLs) and product transfers to sites (STs) (US & EU regions) from submission to on-time launch and maximize revenue from your NPL business, Providing support for conducting trials for evaluating New Technologies/ PAT Tools for better process understanding

• Pelletization (Wurster coating)
• MUPS Compression
• Granulation (Top spray, Rapid Mixer)
• Compression
• Coating (Film & Functional)
• Hot melt extrusion
• Extrusion & Spheronization
• Roll compaction

• Capsule (Pellets filling & mini tablet filling)
• Tablets (Bilayer, and Modified release tablets & MUPS)

• Knowledge of Regulatory aspects of PAS, CBE30, CBE0 Filing, SUPAC guidelines, QbD Approach (ICH Q8), Process analytical techniques (PAT) applied in technology transfer & Continuous Manufacturing process (ICH Q13)
• Computer proficient having knowledge of DOE software (Minitab), Proficiency in handling SAP, Microsoft word, Microsoft excel and Microsoft PowerPoint
• Recognized with the ‘Result Driven’ award in FY22
• Received a Certificate of Recognition for exemplary contributions to the successful EB execution and pivotal BE success of a high-value, complex product for both US and EU markets

• Date of Birth: 06/06/90
• Marital Status: Married

I, V.Laxman Rao hereby declare that the above written particulars are true to the best of my knowledge & belief.

Problem Solving, Project Leadership, Optimizing & Establishing robust process, Sterile processing, Complex Generic, Collaboration, Training, Team Management, Budgeting, Device Development, Rapid mixer granulator, Fluidized bed processor (Top and Wurster spray), Compression machine, Coating machine, Capsule filling machine, Hot melt extrusion & extruder, Spheronizer, To be a part of pharmaceutical organization that utilizes my skills and abilities and that offer professional growth while being resourceful and innovative. To work conscientiously and remain committed to carry out the task assigned to me enthusiastically.

Looking for an experience Managerial position in Project management / Process development / Technology transfer/ Process improvement department that offers me an opportunity for advancement in my career endeavours, where I can utilize my current technical skills, knowledge and expertise gained over the years in manufacturing, product-process development and technology transfer dept. for oral solid/liquid and ophthalmic dosage forms.