Loganathan S
AVP at Stelis Biopharma
- Role
- AVP at Stelis Biopharma
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
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.
Experience
AVP
Dec 2020 — Present · 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
1996 — 1997
Indira Gandhi National Open University
MBA, Operations research
2004 — 2010
Kendriya Vidyalaya
B.Sc, Chemistry & Biology
1993 — 1996
Institute of Pharmaceutical Education and Research (IPER) - PUNE
Post Graduate in Pharmaceutical Packaging, Pharmaceutics Packaging
2003 — 2004
Bangalore University
B.sc, Chemistry, Botony & Zoology
1994 — 1997
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