19 Aug
|
Amneal Pharmaceuticals
|
Ahmedabad
19 Aug
Amneal Pharmaceuticals
Ahmedabad
New Product Launches :
- Ensure the timely Launch of New Products across all Indian sites, mainly from Injectable business.
- Oversee the timely availability of materials for new product.
- To understand the technical challenges associated with the execution of new products in commercial scale for the first time (ex. Understanding of Batch Deviation issues, OOS, FDA queries related to products)
- To coordinate with all Cross-Functional Teams (CFTs) in India/US & provide updates on ANDA/NDA review progress, IP landscape, manufacturing plan and target launch timeline through bi-weekly NPL meeting.
- Coordination with Portfolio, R&D;, ARD, RA, Purchase, Quality, Manufacturing and commercial
- To facilitate the resolution of any bottlenecks or areas of concern impacting launch timeline.
- To proactively address capacity constraints to accommodate upcoming recent launches which includes activities such as scale-ups, line transfers, and site transfers.
- To act as the Project Manager for the Site Transfer of Injectable products from Amneal's US sites/CMOs to Amneal India (Ex. Batch size determination in case of Technology Transfer)
- To ensure the timely initiation of Artwork activities and ensure use of right version of artworks in product packaging (ex. Barcode gradation improvement)
- To lead the capacity expansion project by ensuring the timely execution of scale-up batches and facilitating FDA submissions.
- To focus on timely New Product Launches for inhalation (MDI/DPI) products, against commitment for Ireland site team.
Education:
- Bachelors Degree (BA/BS) B.E. - Required
- Master Degree (MS/MA) ME - Preferred
Experience:
- 15 years or more in 15+ Years relevant experience
📌 Deputy General Manager, Supply Chain Planning (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad