Senior Research Scientist, AR&D

Designation : Senior Research Scientist

Function : Research and Development

Functional Area : AR&D - Injectable

Job Role Summary : Analytical method development, validation for new products, comprehensive testing of API and finished dosages, Review of laboratory data, instrument logbook and reports wherever applicable, Initiation of departmental CCR’s and tracking the progress to execute the proposed changes through QMS system, Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. 

Job Profile :

• Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. 
• Applies AQbD approach to analytical method development where applicable. 
• Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. 
• Prepares working plan for assigned projects and provides timeline to Manager. 
• Develops stability indicative analytical methods for drug substance and finished product  
• Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. 
• Responsible for method verifications and publishing of analytical methods. 
• Performs all analytical tests for drug substance, PE/PO Samples,  including assay, related compounds, identifications and wet chemistry for API evaluation. 
• Conducts lab investigations for OOS and OOT results. 
• Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. 

Job Requirements :

• BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment. 
• Knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. 
• Knowledge in HPLC method development and method validation. 
• Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports.  
• Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities 
• Should possess troubleshooting knowledge on Instruments and analysis. 
• Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Chromatographic method development and validation.

Work / Job Experience : 2-5 Years

Type of Experience : Analytical Development, Method Validation, Method Transfer, Technology Transfer

Academic Qualifications :

A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. 

Job Post Link : https://tinyurl.com/43nuvw5k