Job Description
Major purpose of the Job:
-Formulation development of oral solid and liquid oral products for regulated, semi regulated and other international market.
- Technology transfer, Process and Cost optimization, Support in commercial validation and Market launch
- Lead, guide, mentor and manage a team of scientist and technical staff towards timely product delivery.
Key Responsibilities:
- Preparation of strategies for new product development as per the market needs.
- Responsible for Pre-formulation and formulation activities as per QbD approach towards developing robust, bioequivalent and stable products.
- Responsible for end to end integration of development activity at lab scale to regulatory filling and commercial launching.
- Preparation of strategies and documentation for executing scale up and EB batches at plant location.
- Troubleshooting and resolving manufacturing or quality-related issues following company quality policy.
- Responsible to address regulatory deficiencies, striving for timely and early product approval.
- Process validation activities and technology transfer of product from lab scale to commercial scale.
- Alternate source development of API and Excipient towards cost improvement of existing products for regulated and other international market.
- Ensure projects are developed and completed on time within stipulated budget, meeting all quality and regulatory expectations.
- Actively participation in meetings with internal stakeholders and external clients and translate all technical or strategic input into actionable tasks with monitoring of project progress.
- Contribute to the ideation, conceptualization and development of new, novel, innovative and patentable products.
- Manage day-to-day activities of the team, assign tasks, mentor associates, and provide regular feedback.
- Collaborating and building strong working relationships with cross function team to drive timely regulatory filing and successful market launch.
- Driving continuous improvement in system and processes, leading to technical, solution and cost improvement enhancements.
- Fostering and promoting a positive, transparent and collaborative team environment,
- Act as a bridge between the team and upper management, providing regular updates and feedbacks.
- To get need base training for Excellence and continuing education as and when required.
