Sachin Rewaria

Biography

Senior Scientist Company Name Aurobindo Pharma Dates Employed May 2015 – Present Employment Duration 2 yrs 5 mos Location Hyderabad Area, India Analytical development, injectables Asst. General Manager Company Name Gland Pharma Limited Dates Employed Jul 2010 – May 2015 Employment Duration 4 yrs 11 mos Location Hyderabad Area, India  Establish and deploy analytical method life-cycle management policies in line with the product development strategy defined by the Management.  Responsible for communication with the cross functional teams regarding the project health and timelines.  Provide analytical support during manufacturing process design, optimization, validation and transfer.  Collaborate with Formulation Development, Regulatory Affairs and Quality to define drug product quality attributes, testing methods, stability profiles, product performance attributes, and release and in-process specifications.  Lead scientific team of analytical scientists and leverage the strength of people effectively.  Provide strategic direction for outsourcing analytical development and methods to another lab's wherever required.  Establish internal SOPs for the laboratory.  Ensure compliance of AR&D Lab to cGLP and responsible for Audits at R&D.  Guiding the analysts regarding the latest advancements in pharmaceuticals and updating them for the auditing trends.  Design and Deploy an effective training and skill enhancement plan for the Analytical Team.  Create Effective Project Plans for Analytical Team and ensure project objectives are met.  Continuously analyze and improve the Analytical Aspects of Process/Product through method enhancement/improvement.  Implement relevant industry best practices and regulatory guidance’s.  Enhance and positively contribute to analytical inputs as required by QC team at manufacturing sites.  At times, the job may require travelling to various sites during tech transfer phase of the project.  Responsible right from the API selection till the product approval across the various geographies  Responsible for providing the time lines for the regulatory analytical queries

Research Interest

Pharmaceutical Science