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 recent 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 Current 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