Deputy Manager, Analytical method transfer tCognition

5.0 - 9.0 years

0 Lacs

karnataka

On-site

You will be joining our team as a Deputy Manager/Manager, Analytical method transfer, responsible for delivering developed analytical assays from R&D scale to GMP-compliant commercial quality control labs. Your role will involve overseeing projects related to analytical method transfer, collaborating with cross-functional teams, and ensuring technology transfer and assays qualification activities are conducted in compliance with GLP and GMP standards. The ideal candidate will possess expertise in cGMP, regulatory requirements, technical troubleshooting, method transfer, method validation, technology transfer, and laboratory techniques to support routine testing and release of research and cGMP grade materials. You will be directly involved in drafting technology transfer documents, risk assessments, process FMEA, method validation protocols, facility fit assessments, and other related activities necessary for the release and testing of microbial and mammalian fermentation-based products. You should have familiarity with analytical assays such as HPLC, GC, SDS-PAGE, agarose gel electrophoresis, densitometry, dd-PCR, RT-PCR, ELISA, UV-Visible spectrophotometry, western-Blot, as well as microbiological techniques like BET, BioBioburdend Sterility testing. Additionally, the position may entail assisting in cell bank testing and release under cGMP regulations and coordinating with third-party collaborators for external testing as needed. Your responsibilities will also include authoring and reviewing research studies, compiling experimental data, and contributing to protocols, study reports, and publications with minimal supervision. You will work as part of the method transfer and method validation team, ensuring timely and successful completion of process transfers while addressing any unexpected technical challenges. We are looking for individuals who are enthusiastic, highly motivated, and capable of multitasking. The role requires working collaboratively within a team environment and independently across various aspects of projects related to microbial-derived products.,

Posted 3 days ago

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