Highlights:

Skills:Injectable, Parenteral products development

Senior Manager 03/2019 - current
Biological E Ltd, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Responsible for handling of teams in Formulation R&D development. Development of injectable products for regulatory markets
Formulation development and scale-up of Injectable solutions and Lyophilized Injections for US, Europe and Canada markets. Led the team of scientists in the formulation development department. Preparing documentation like Product development report (PDR) based on CTD and QbD requirements. Product Development based on QbD concepts. Implementation of design of experiments (DoE) approach during formulation development for optimization and to construct the design and control space according to the QbD concepts. Preparation of documents like Product development strategies, Technical summary reports, Exhibit batch documents and Product development report etc. Involvement in multidisciplinary work areas in the product development such as IP, regulatory, scale-up, project management etc. to execute the products smoothly. Authoring responses to the regulatory queries.--
Senior Research Scientist 07/2016 - 02/2019
Neuheit pharma technologies Pvt Ltd, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Responsible for handling of teams in Formulation R&D development. Development of injectable products, solid orals and liquid oral products for regulatory markets
Formulation development and scale-up of Injectable solutions, Lyophilized Injections, Tablets, Capsules(IR & ER)and oral solutions for US and Europe markets. Led the team of scientists (5 members) in the formulation development department. Prepared documentation like Product development report (PDR) based on CTD and QbD requirements. Implemented design of experiments (DoE) approach during formulation development for optimization and to construct the design and control space according to the QbD concepts. Well versed with the preparation of documents like Product development strategies, Technical summary reports, Exhibit batch documents, Product development report etc. Exposed to multidisciplinary work areas involved in product development such as IP, regulatory, scale-up, project management etc to execute the products smoothly. Initiated Technical Forum to discuss the complex problems encountered and troubleshooting in the product development of other teams. Writing the responses to the queries received from various regulatory agencies.--
Manager 08/2012 - 06/2016
Leiutis pharmaceuticals pvt Ltd, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Responsible for handling of team in Formulation R&D development. Development of injectable products and solid oral products for regulatory markets
Completed formulation development and scale-up of Injectable solutions, Lyophilized Injections, and oral solutions for US and Europe markets. Led the team of scientists (12 Members) in the formulation development department. Prepared documentation like Product development report (PDR) based on CTD and QbD requirements. Developed products based on QbD concepts. Implemented design of experiments (DoE) approach during formulation development for optimization and to construct the design and control space according to the QbD concepts. Well versed with the preparation of documents like Product development strategies, Technical summary reports, Exhibit batch documents, Product development report etc. Exposed to multidisciplinary work areas involved in product development such as IP, regulatory, scale-up, project management etc to execute the products smoothly. Writing the responses to the queries received from various regulatory agencies.--
Junior Manager 09/2009 - 08/2012
Dr Reddy's Laboratories ltd, Hyderabad, Telangana India
Industry: Pharmaceutical Industry
Development of parenteral and solid oral projects
Completed formulation development, scale-up and filing of Injectable solution and tablets for US market. Completed formulation development and scale-up of Injectable solutions, Lyophilized Injections, Tablets and Capsules for US and Europe markets. Documenting experimental details in Product development notebooks. Performing pre-formulation studies and developmental studies for all the projects. Preparation of documents like Product development strategies, Technical summary reports, Exhibit batch documents, Product development report etc. Preparation of Product development report based on CTD and QbD requirements.--

Kakatiya University 08/2003 - 06/2007
Warangal, Telangana, India
Degree: Bachelor's Degree
Major:Pharmacy
Graduated with first class(74.6%)

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