Deputy Manager MSAT- - Bangalore Urban, India - tCognition

Description

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.