Achyut Khire
Device Expert with MS&T at Sandoz | Research & development (R&D) | Innovation Management | New Product development (NPD) | Medical device | Drug-device combination products | UDCT/UICT/ICT | IIMB | IITB
- Role
- Device Expert at Sandoz
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Achyut Khire
I am a technology-focused professional with a goal-oriented and strategic mindset. I have…
Experience
Device Expert
May 2023 — Present · Navi Mumbai, IN
Outline:At Sandoz our work is focused on improving access to medicines, access to medical information and access to medical capacity building. At Sandoz, our purpose is to pioneer access for patients. Our business ambition is to be the world’s leading and most valued generics company.Key responsibilities:1. Led life cycle management (technical operations) for combination products and class I / IIa / IIb devices in 4 EU manufacturing sites and 2 R&D sites.2. Managed global portfolio of >100 products with 11 biosimilars and small molecules in Respiratory, Ophthalmic, injectable and transdermal divisions.3. Directed risk management, design history file, device master record and post marketing surveillance for single integral products, co-packaged systems and procedure packs as per EUMDR.4. Facilitated design transfer / technology transfer of combo product design files for USFDA and medical devices for MDSAP.Key achievements:Total market size under the basket of impact is more than Euro 1 Billions.
Education
Institute Of Chemical Technology
Master’s Degree, Pharmaceutical Technology
2007 — 2009
Institute Of Chemical Technology
Doctor of Philosophy (Ph.D.), Pharmaceutics
2009 — 2014
Savitribai Phule Pune University
Bachelor’s Degree, Pharmacy
2003 — 2007
Skills
- Pharmaceutical Research
- Pharmaceutics
- Organic Synthesis
- High-Performance Liquid Chromatography (Hplc)
- Hplc
- Downstream Processing
- Uv/Vis
- Lc-Ms
- R&D
- Chemistry
- Organic Chemistry
- Formulation
- Technology Transfer
- Good Laboratory Practice (Glp)
- Drug Delivery
- Forms Development
- Chromatography
- Glp
- Pharmacokinetics
- Uv/Vis Spectroscopy
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