Ramesh Babu Kota

Experience

• 

  Aurobindo Pharma

  May 2004 - Mar 2008

  Research Associate -IV

  1. Initially joined as research associate-1 and promoted up to research Associate-IV position. 2. Responsible for complete analytical support to formulation development for various projects like solid oral dosage, Injectable (as liquid, dry powder), oral suspension formulations. 3. Also responsible for technology Transfer to plant QC. 4. Independently handled the different section of QC/QA activities for testing of Raw and packaging materials, in-process, finished products and checking of relevant documents. With analytical exposure to various formulations like solid oral dosage, injectable, small volume and large volume parenteral and solutions. Show less

• 

  Jubilent organosys ltd

  Jun 2008 - Jan 2010

  Research Assaociate

  2008-2010 worked in Jubilant .Worked in analytical method development for method development for various oral solid dosage units

• 

  Kemwell Biopharma Pvt. Ltd.

  Jan 2010 - Jun 2010

  Senior Scientist

  1. Worked as Scientist lead the team of 4 Executives for development and support analysis. 2. Good understanding in Analytical method development and validation of Pharmaceutical products. 3. Complete support to the Formulation development with the objective to reduce their development time by planning and executing various analytical experiments. 4. Responsible for development of analytical methods for customer support. 5. Preparation and execution of different method validation protocols and ensuring validation of methods as per current ICH guidelines. 6. Responsible for development of analytical methods for formulation for discriminative and bio-relevant media of dissolution. 7. Planning and execution of various Pre-formulation/compatibility studies of API and excipients from the point of view of related substances in formulation to solve formula/composition related issues and to predict the stability. 8. Responsible for answering the analytical queries before and after submission with regulatory department and external regulatory authorities. 9. Responsible for vendor development audits. 10. Train the team members in specific areas and analysis of complex products. Show less

• 

  Dr. Reddy's Laboratories

  Jun 2010 - now

   Analytical Expert (Manager) in DR Reddy’s Laboratories, IPDO, Innovation Plaza, and Hyderabad, India from December 2017 to till date.  Joined as assistant manager in 2010 in oncology Laboratory in for parenteral and oral solid dosages in oncology products.  Promoted as Deputy Manager in 2014 and continued to support in oncology laboratories as group leader for high performance technical Team. Delivers 505(b2), 505(j) and Q1/Q2 formulations.  Promoted as Manager in 2017, working as analytical expert for new product development and Technology transfer of new products to overseas in china and Europe.  Onsite International Experience- 3 months –Worked as Analytical development Expert in HDS, Wuxi (Contract manufacturing Organization) on Complex Injectable development.  Experience in contract external manufacturing site (China marketCMO’s) evaluation for product manufacturing feasibility and quality control activities.  Onsite International Experience- 1 months –Worked as Dr Reddy’s Representative at SGS laboratories and Contract research organizations in Shanghai and Hangzhou for Analytical method development and Validation for Complex Characterization Technology transfer. Show less Joined as Asst. manager (Scientist) in oncology lab skilled for both oral solid dosages and parenterals.Project initiating from Development strategy note followed analytical development, validation and Technology transfer involved in every stage of product execution.Present working as senior scientist. Plan, review and organise of analytical development, validation, technical summaries review and planning Pharmaceutical equivalent studies, Dilution studies, Justification for validations and impurity profiles for drug products.....ETC Show less

  • Analytical expert ( Associate Director)

    Apr 2019 - now

  • Analytical expert (Manager)

    Dec 2017 - now

  • Senior Scientist

    Jun 2010 - now