arul marimuthu

I have 10 years of experience in downstream processing of therapeutic proteins derived from microbial and mammalian sources. I excel at process development, scale-up, technology transfer, PPQ, CPV, and QbD analysis. With the information gathered during my professional career, I can work independently and at present leading a team in MSAT downstream.

Process development for post approval changes and comparability assessment evaluation as per ICH-Q5E guidelines for regulatory filing for Microbial and Mammalian cell culture based therapeutic proteins. 

Troubleshooting the issues encountered during clinical batch operations and supporting investigation team in identifying the appropriate root cause for process related deviations Coordination with Various CFT teams to drive the project deliverables related to process development and technology transfer for Microbial and Mammalian downstream process.

 Responsible for Process characterization, SDMQ studies and control strategy establishment Responsible for establishment of CQA's, preparation of justification of specifications document and In- process control & test documents Managing daily operational activities of team .Technical Competencies and empowering the team on various technical and soft skills.Developing high performance team and individuals Mentoring and coaching direct and indirect reporting team members.Insulin downstream process scale-up from pilot scale to commercial scale Evaluation of Resin life time on scale down model Scale up studies and Technology transfer document preparation Process characterization studies Development of various column cleaning/regeneration approaches to increase chromatography resin life time

2007-2009, Master of Science: Biotechnology Periyar Univerisity - Tamilnadu, India

2004-2007, Bachelor of Science: Biotechnology Bharathidasan University - Tamilnadu, India