Raja Sekhar Chitikina

To pursue a career in the area of Formulation Research & Development that gives me scope to utilize and update my knowledge and skills in accordance with the recent trends.

• Formulation Research and Development
• Technology Transfer

• Literature survey, Pre-formulation studies and formulation process
• Identification and optimization of suitable process parameters and components for manufacturing the Product
• Preparation of the control correspondence
• Preparation and reviewing of Technology transfer documents for Pilot/Exhibit/commercial batches
• Experienced in writing of justification for OOS’s and OOT’s observed during stability of the product life cycle for the products developed
• Having technical expertise in compilation and interpretation of Formulation and Analytical data
• Preparation of Pharmaceutical Development Reports (PDR) for regulatory submission
• Having knowledge in preparation and review of BPCR’s
• Experienced in proposing Formulation approaches for product development and Preparation of Protocols and Reports for various developmental activities
• Handling of exhibit batches for US & Europe submission
• Handling of exhibit batches for WHO submission
• Co-ordination with various departments like purchase, production, QA-QC and regulatory for smooth development and execution of drug product
• Involved in preparation and revision of SOP & maintenance and calibration of equipment
• Preparation of stability protocols, conducting stability studies and data interpretation
• Preparation of SLIA and URS documents for procurement of new equipment’s as per laboratory requirement
• Maintaining and improvement of standards for good Laboratory/Manufacturing practices

• Formulation development of Onco/Non-Onco drug products (Simple Injections and Lyophilized products)
• Formulation development of Ophthalmic drug products
• Formulation development of Vaccine drug products

• Lyophilized, Liquid (Onco/Non-onco) injectables for Regulatory market
• Ophthalmic drug products for Regulatory market
• Lyophilized, Liquid Vaccines for Regulatory market

• Father's Name: Ch. Ram Babu
• Date of Birth: 10/02/90
• Marital Status: Married