Loganathan S
AVP @Stelis Biopharma
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WORK HISTORY
AVP @Stelis Biopharma
Bengaluru, IN
Heading Device Development & Pharmaceutical Packaging Drive Stelis CDMO business by supporting customer in development of drug delivery devices such as Needle based auto injector systems for single/ multi-dose, generic Auto Injectors for US,EU,ROW & Domestic.Facilitate customers (Inhouse & external) with Design, develop & execute Design Verification with Validated Test method for medical devices in house.Guide team to prepare Technical dossiers, Risk assessment & DHF for medical devices.Participate in discussion with US, EU regulatory department during device development.
EDUCATION
CIPET
Post Graduate in Plastics technology, Plastics Technology
Indira Gandhi National Open University
MBA, Operations research
Kendriya Vidyalaya
B.Sc, Chemistry & Biology
Institute of Pharmaceutical Education and Research (IPER) - PUNE
Post Graduate in Pharmaceutical Packaging, Pharmaceutics Packaging
Bangalore University
B.sc, Chemistry, Botony & Zoology
ABOUT LOGANATHAN S
A seasoned professional with more than 22 years of robust experience in the Design & Development,Quality Assurance, Regulatory compliance, Validation, Project,Production Management, Strategic Planning, Business Development, DHF remediation & Product development of Class I to medical devices, drug delivery devices for Pharmaceutical, Packaging & plastic components industry. Deft at pharmaceutical packaging & development with domain expertise at development and Validation for Plastic Packaging for pharmaceutical drug delivery system, Medical Device and Documentation, Regulatory submissions for 510 K, PMA,NDA & ANDA filings for various Class II & Medical device,Pharmaceutical drug delivery devices,Quality assurance and review of data for Compliance & Remediation of Class II & Medical device DHF. An ISO 9001,14001 & 13485, FMEA, DMF & Regulatory Filings, Sterilisation Validation, and Lean Six Sigma Green Belt certified professional. Proficiency at developing & streamlining systems with proven ability to enhance operational effectiveness and meet operational goals within the cost, time & quality parameters. Expertise in conceptualizing profitable production projects and managing operations encompassing procurement, quality, etc. A keen planner, strategist & implementer with expertise in establishing & managing entire operations with key focus on top line & bottom line profitability by ensuring optimal utilization of the resources.
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