Scientist Bharat Serums and Vaccines Limited

5.0 - 9.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As a candidate for this role, you will be responsible for the following key responsibilities: - Thorough knowledge of HPLC based analysis of recombinant proteins including RP-HPLC, SE-HPLC, and glycan analysis. - Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines. This includes writing and reviewing protocols, transfer plans, and reports. - Carry out day-to-day analytical work and collaborate with the Cell culture and downstream teams in Biotech R&D. - Set up product-related test/release specifications and analytical protocols for Biotech products. - Design in-house/outsource methods for Physico-chemical characterization of biological products. - Coordinate with QC for the smooth implementation of new methods. - Maintain equipment logs and documentation in the lab. - Monitor and maintain stability of various products in Biotech. - Prepare lab-related documents, regulatory submission documents, and provide QC support (SOP, STP, COA, MOA, Specification). - Interpret data and write reports in support of regulatory submissions. - Review analytical data for in-process & stability related activities. Qualifications required for this role: - Strong knowledge of HPLC based analysis of recombinant proteins. - Experience in method development, qualification, and transfer following ICH/USP/EP/IP guidelines. - Good understanding of analytical work in a Biotech R&D setting. - Ability to design analytical protocols for Biotech products. - Knowledge of Physico-chemical characterization of biological products. - Proficiency in interpreting data and writing reports for regulatory submissions.,

Posted 3 days ago

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Executive/ Sr. Executive- QC Zydus Group

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be joining the VTC MFG. QC Department as a Probationer-HO Staff, with a primary responsibility of ensuring the quality control of manufacturing processes. The ideal candidate should hold a M.Sc. degree in Biotechnology, Biochemistry, or Microbiology and have at least 3-7 years of hands-on experience in a relevant field, preferably with a background in the pharmaceutical industry. Your role will involve conducting various analytical tests and procedures such as RP-HPLC, SEC-HPLC/SE-HPLC, Dionex, IC/Ion Chromatography, Biochemical analysis, UV spectrophotometer, Protein, O-acetyl. It is essential to have a good understanding of these techniques and equipment to perform accurate quality assessments. As a member of the VTC MFG. QC team, you will play a crucial role in upholding the quality standards of the manufacturing processes. Your expertise and attention to detail will contribute significantly to ensuring the production of high-quality products that meet regulatory requirements and customer expectations.,

Posted 2 weeks ago

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