We are looking for a #Deputy_Manager / #Analytical_Method_Transfer
Experience: 10 to 13+Years
Location: Bengaluru
Key Skills :
To execute analytical method transfer and its qualification/validation from R &D to commercial QC scale.
? Prepare technical documents such as CTD (Common technical documents), technology transfer, ADR (Assays development report), facility fit assessment & process FMEA/risk assessment prior to initiating a technology transfer.
? To lead and execute validation studies such as execution of process performance qualification (PPQ), cleaning validation, & continuous monitoring of transferred process.
? Preparation of SOPs, STPs (Standard test protocols) & specifications required for routine testing and release of cell banks, routine in-process samples & formulated products such as drug substances and drug products. etc. with minimum supervision.
? Ensure effective, high-quality, timely and appropriate documentation in physical or electronic laboratory notebooks, LIMS, Logbooks etc. and other laboratory software to Maintain diligent and organized records.
? Effectively maintain good communication and collaborate with cross-functional colleagues
for successful execution/completion of projects.
? Prepare and maintain buffers, reagents, and equipment operation such as HPLC, Chromatography, ELISA plate reader, isolator, thermal cycles, etc.
? To perform statistical data analysis and data trending such as MVDA (multi-variant data analysis), Data management, and deriving conclusions from a gathered data by means of defining further strategies.
? Identify, evaluate, and implement new and existing technologies to improve product testing efficiency, control, and management of routine samples for validation studies, stability studies etc.
? To help and support the process characterization activities the process transfer team and to collaborate in identifying and testing product and process-related impurities, their removal and virus clearance studies etc.
? Collaborate and coordinate with Process Engineering, Project Engineering, QA/QC, Program, and Management teams.
? Provide guidance during outgoing tech transfer and scale-up of process as and when required.
? Clearly communicate results and recommendations to colleagues, managers, and senior management, assisting in project decision-making.
? Work on problems of diverse scope (bridging upstream and downstream processes, manufacturing anomalies, and analytical science), and guide junior scientists.
Send your resume to [email protected]
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