Abbott - Research Scientist

About the Job :

We are seeking a skilled and detail-oriented Analytical Scientist to join our Quality Control team.

The ideal candidate will be responsible for the development, validation, and transfer of analytical methods for various pharmaceutical dosage forms, ensuring compliance with regulatory standards and internal quality Accountabilities and Responsibilities :

• Develop, validate, and transfer analytical methods for pharmaceutical dosage forms including Oral Solids, Oral Liquids, Injectables, and Nasal Sprays.
• Perform literature search related to drug substances and create analytical profiles.
• Execute analytical method transfers and ensure smooth handover between development and quality control teams.
• Analyze routine samples including product development batches, stability study samples, and raw materials.
• Operate and calibrate analytical instruments and equipment.
• Perform qualification of working standards.
• Review analytical data and support product release decisions (as assigned).
• Ensure accurate and timely documentation of all analytical activities in accordance with Good Documentation Practices (GDP).
• Work in the laboratory while adhering to Good Laboratory Practices (GLP) and safety protocols, including proper use of PPE.
• Prepare Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), product Specifications, Certificates of Analysis (COAs), and stability reports.
• Prepare Raw Material Specifications and STPs.
• Troubleshoot analytical issues, solve technical problems, and respond to analytical queries.
• Review analytical development and stability data.
• Perform analytical activities related to the Quality Control Department.
• Execute any other tasks assigned by Competencies Required :
• Strong knowledge of Analytical Method Development, Method Validation, and Method Transfer processes.
• Understanding of regulatory requirements and quality standards applicable to pharmaceutical industries (e., ICH, FDA, GMP).
• Ability to perform analysis in compliance with Good Laboratory Practices (GLP).
• Strong attention to detail and excellent documentation skills.
• Good problem-solving and troubleshooting Skills / Technical Expertise :
• Hands-on experience with the following analytical instruments :
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• UV-Visible Spectrophotometer
• Infrared Spectroscopy (IR)
• Dissolution Test Apparatus
• Disintegration Test Apparatus
• Viscometer
• Differential Scanning Calorimetry (DSC)
• Malvern Particle Size Qualification : B.Sc. / M.Sc. in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a related field

(ref : iimjobs.com)