Tushar Jadhav
Associate Director - Strategic Topical Formulation Leader | USA New Drug (NDA), Generic Drug (ANDA) R&D-Formulation Development | QBD-Chemistry Manufacturing Controls (CMC) | High Quality Submissions in Advanced Markets|
- Role
- Associate Director-topical Formulation R & d at Viatris
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Tushar Jadhav
Every year, 30–40% of topical drug submissions get delayed or rejected not because the science is weak, but because of gaps in:Formulation strategyCMC planningTech transfer execution, and Unstable product performanceAdd: Inconsistent data packages Unclear QTPP–CQA alignment, and Poor scalability, ….and companies lose months and millions.So, the real question becomes:How do we build topical products that scale smoothly, stay stable, meet global regulatory expectations, and reach the market faster without repeated failures?For years, I’ve been digging into this problem:Studying failed batchesOptimizing DOETightening control strategiesImproving documentation disciplineStrengthening tech transfer systems, and Using AI to cut research time and improve stability prediction accuracy.All of this shaped the approach I bring to R&D today.Hi, I’m Tushar, an Associate Director – Topical Formulation R&D at Viatris (Mylan Labs) with 18+ years of experience developing and commercializing topical and multi-dosage products for the US, Europe, China, and ROW.These are some of my accomplishments: Led 50+ product development projects and contributed to 20+ successful ANDA submissions Built and scaled 3+ formulation labs from scratch Regularly travelled to Taiwan for FDA inspection support & product transfer activities Awarded US & China patents for Topical Flunisolide Compositions Fluent in Mandarin, with hands-on experience in global regulatory environmentsMy work revolves around turning complex formulation challenges into commercially successful, stable, and regulatory-compliant drug products.I’m always open to connecting, exchanging ideas, solving formulation challenges, and discussing innovative approaches to building robust topical products.Let’s connect and talk about science, strategy, or smart ways to accelerate development.Expertise:Formulation Development | QbD | DoE | QTPP–CQA Mapping | Tech Transfer | Scale-Up | Exhibit Batches | PDR | Stability | Process Optimization | GMP Documentation | CMC Writing | Risk Assessment (FMEA)| AI in Formulation | Data Trending | Project Leadership | Cross-Functional Collaboration | Vendor & Supplier Management | Budgeting & Resource Planning | Problem-Solving | Stakeholder Alignment | Audit support | Query Response.
Experience
Associate Director-topical Formulation R & d
Sep 2022 — Present · Hyderabad, IN
Established a state-of-the-art lab for high-quality topical formulation development at Viatris. • Applied Quality by Design (QBD) principles to enhance formulation processes and ensure product quality. • Facilitated effective communication among diverse teams across multiple countries, fostering collaboration. • Managed technology transfer and stakeholder relationships to align project goals and drive success.
Education
Annamalai University
M.Pharmacy, Industrial Pharmacy
2006 — 2008
North Maharashtra University
Bachelor's degree, Pharmacy
2001 — 2005
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