Deputy Manager MSAT-
1 month ago
Job Responsibilities:
• To execute process scales up and technology transfer of developed process from PD scale
to a GMP or a pilot scale of chromatography operations ranging from 10-mL to 100-L.
Prepare technical documents such as CTD (Common technical documents), technology
transfer, PDR (Process development report), facility fit assessment and 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 and continuous monitoring of transferred process.
• Preparation of SOPs, MFR (Master formula records) and BMR (Batch manufacturing
records) etc. with a minimum supervision.
• Ensure effective, high-quality, timely and appropriate documentation in physical or
electronic laboratory notebooks, e-BMR, Logbooks etc. Maintain diligent and organized
records.
• Effectively maintain good communication and collaborate with cross-functional colleagues
for successful execution/completion of projects.
• To prepare reagents, buffers, and equipment operation such as TFF, Chromatography,
micro-filtration, continuous centrifuges, depth filtration as needed to support technology
transfer and execution of validation batches at different scales.
• 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.
• To identify, evaluate, and implement new and existing technologies to improve
downstream process efficiency, control, and understanding (In-line dilution and in-line
conditioning system, continues mode of purification, mixed mode resins evaluations etc.).
• To perform process characterization by scale down model activities to identify and evaluate
the product and process related impurities, their removal and virus clearance studies etc.
• To collaborate and coordinate with upstream Process Engineering, Project Engineering,
QA/QC, Program, and Management teams.
• Provide guidance during outgoing fermentation tech transfer and scale-up.
• 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), provide guidance to junior scientists.
• Identify and mitigate potential risks associated with process transfer and scale-up,
developing and implementing mitigation strategies.
• Additional responsibilities not listed may be assigned as needed by leadership.
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