Senior Team Leader - Formulation Development

About Strides Pharma Science Limited

Strides Pharma Science Limited is a fully integrated global pharmaceutical company headquartered in Bangalore, India, with a presence in over 85 countries. The company operates world-class manufacturing facilities in India, the UK, Italy, and Africa, and boasts a dedicated R&D center in Bangalore. Their operations cover pharmaceuticals (differentiated and branded generics), development and manufacturing of intermediates, APIs, and formulations, alongside contract research and biopharma activities.

Role Overview

The Senior Team Leader in Formulation Development holds a critical role in managing projects ensuring completion within timelines, along with close coordination across multiple departments to drive successful product development and regulatory compliances.

Key Responsibilities

• Lead project execution ensuring timelines are met as committed.
• Calculate API amounts based on project needs.
• Assess the feasibility of new projects prior to initiation.
• Collaborate with project management to adhere to defined schedules.
• Work alongside sourcing teams to guarantee supply of necessary materials for development activities.
• Coordinate with licensing teams to secure required licenses for submission batches.
• Facilitate transfer processes between R&D and manufacturing departments to ensure smooth commercialization of products.
• Provide timely documentation to support regulatory dossier preparation and submissions, and address any regulatory queries.
• Collaborate with cross-functional teams to resolve regulatory shortcomings.
• Prepare, approve, and implement standards operating procedures (SOPs) and conduct training and maintain records.
• Ensure team compliance with established systems and procedures.
• Design and execute experimental designs (DoE), optimize composition and processes, perform statistical analyses and data interpretation, and prepare related reports.
• Prepare Product Development Protocols (PDP) and Product Development Reports (PDR).
• Troubleshoot issues arising during routine formulation development tasks.
• Evaluate and justify bioequivalence (BE) failures and impurity increases observed in stability studies.
• Lead and supervise lab-scale development and formulation projects.

Additional Information

This leadership role requires a hands-on approach with multidisciplinary coordination ensuring product development success from research through commercialization, adhering strictly to regulatory and quality standards.