Lalitha Sankaranarayanan
Assistant Manager @ HiMedia Laboratories M.Sc Microbiology Senior R&D - Quality leader| Global Product lifecycle management |Biotech| IVD | Forensic compliance
- Role
- Assistant Manager R & d at HiMedia Laboratories Pvt. Ltd.
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Lalitha Sankaranarayanan
Biotechnology R&D and Quality leader with 18+ years of experience in microbiology, molecular biology, analytical sciences, and global specification management.* Proven track record of leading cross-functional and international teams to deliver high-quality, compliant products across US, EU, and APAC markets.* Skilled in molecular techniques, method development, validation, contamination control and regulatory submissions, with expertise in aligning global standards to accelerate product approvals.* Recognized for building high-performing teams, driving innovation, and shaping R&D strategies that optimize processes, reduce timelines, and enable sustainable business growth
Experience
Assistant Manager R & d
HiMedia Laboratories Pvt. Ltd.
Apr 2023 — Present · Mumbai, IN
Heading a team for the development of Invitro transcription reagents, raw materials for mRNA Vaccines and Molecular biology lab consumables.Governing the quality aspects of Raw materials required for the manufacturing of Molecular biology kits and reagentsHeading a team for QC of Molecular biology grade chemicals.Handling a team for implementation of GHS labelling and preparation of Safety Data Sheet through SAP as per QMS compliance.SAP trainerGuiding a Regulatory team for application of CE/ IVD certification for Molecular biology lab consumables.Guiding a regulatory team for implementation of GDP, GMP at R&D, QC and Production as per ISO 90••••15 and ISO 13•••••16 guidelines.Governing overall functioning of Production, QC and Raw material requirements of Molecular biology products.Lead Auditor for ISO 90••••15, ISO 13485:2016, WHO-GMP, FDAGuiding a team for uploading of products into GeM portal as well as on the Himedia\'s official website.Heading a team for handling customer complaints and strong technical support related to Molecular biology products.Lead trainer for Chemical handling and Safety/ CHEMDOX Software.Founder Member of MOLECULAR BIOLOGY DEPARTMENT @HiMedia Laboratories Pvt Ltd
Education
Manonmaniam Sundaranar University
M.Sc.Microbiology
2005 — 2007
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