5.0 - 9.0 years

0 Lacs

vadodara, gujarat

On-site

As an Analytical Scientist in our team, you will be responsible for developing and validating robust HPLC methods for the characterization and quantification of biological products such as monoclonal antibodies and recombinant proteins. Your role will involve performing method optimization, robustness studies, and transfer protocols following ICH guidelines. You will also be conducting routine and stability testing by analyzing in-process, release, and stability samples using various techniques including HPLC/UPLC, Capillary and Gel Electrophoresis, UV spectrophotometric methods, Host Cell DNA quantification, and immunoassays like HCP ELISA. In addition, you will be in charge of operating and maintaining analytical instruments such as HPLC, electrophoresis systems, spectrophotometers, and ELISA readers, ensuring their proper calibration, troubleshooting, and performance verification. Your responsibilities will also include preparing and reviewing SOPs, STPs, protocols, reports, and analytical records to comply with regulatory requirements. You will need to maintain accurate documentation in laboratory notebooks and electronic systems. Furthermore, you will participate in internal and external audits and provide analytical data to support regulatory submissions. Collaboration with cross-functional teams including R&D, Quality Control, and Regulatory Affairs will be essential in supporting product development and lifecycle management. You will offer technical support during investigations, deviations, and CAPAs, as well as train junior analysts and new team members on analytical techniques and laboratory practices. To excel in this role, you should hold an M.Sc. / M.Tech / M.Pharm in Biotechnology, Biochemistry, or a related life sciences discipline, along with 4-8 years of relevant experience in analytical development or QC of biopharmaceuticals. Hands-on experience with HPLC method development and ELISA-based techniques is required, as well as familiarity with regulatory guidelines such as ICH, FDA, and EMA, and quality systems. Key skills for this position include strong analytical and problem-solving abilities, attention to detail and data integrity, excellent documentation and communication skills, proficiency in software tools like Empower, Chromeleon, SoftMax Pro, and the capability to manage multiple projects and meet deadlines.,

Posted 3 days ago

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