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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QC associate Dr. Reddy's Laboratories

2.0 - 6.0 years

0 Lacs

hyderabad, telangana

On-site

You will be joining the Quality Control - Analytical team at Dr. Reddys Laboratories Ltd. where your primary responsibility will be to conduct analysis of Biosimilar products including drug substance, drug products, in-process samples, and stability samples. Your role will involve ensuring accuracy in documentation, adherence to safety procedures, reporting discrepancies, and maintaining lab safety. To excel in this role, you will be required to perform various chromatography techniques like RP-HPLC, Glycan, SEC, IEX, and pep map for Biosimilar Molecules. Method validations on RP-HPLC, Glycan, SEC, IEX, and pep map will also be part of your responsibilities. Adhering to GMP practices, good documentation practices, and good analytical practices will be essential. You will also need to adhere to regulatory requirements including internal or external audits, audit readiness, and query response drafting. The ideal candidate for this position should hold a Masters" degree in Biotechnology/BE Biotechnology/B Tech Biotechnology or in the Biochemistry domain. A minimum of 2 to 6 years of experience in QC analytical testing in Biosimilar products is required. In terms of technical skills, proficiency in handling SEC/RP/IEX/Peptide Mapping/Glycan analysis of Biosimilar Products is crucial. Knowledge of cGMP, SOPs, and STPs, ensuring accurate documentation and adherence to specifications is necessary. Adherence to safety precautions and procedures during analysis, emphasizing the importance of lab safety and proper use of Personal Protective Equipment is mandatory. Expertise in handling and upkeep of the chemical and solvent store, as well as method validations on HCP/HCD/CZE/SDS PAGE, will be expected. Behavioral skills such as keen attention to detail, effective communication, collaboration, problem-solving, and upholding ethical standards are also essential for success in this role. If you are looking to be part of a purpose-driven, future-ready, and sustainable organization that aims to reach over 1.5 billion patients worldwide by 2030, then this opportunity at Dr. Reddys Laboratories Ltd. might be the perfect fit for you. For more details and to explore further career opportunities, please visit our career website at https://careers.drreddys.com/#!/.,

Posted 1 week 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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