Fresenius Kabi Oncology Limited is a public company primarily operating in the field of Research & Development and manufacturing of world-class oncology drugs.
Job Title – Research Scientist
Department – Formulation Development
Educational Qualification – M.Pharma in Pharmaceutics from a reputed university
Experience – 2-3 years of experience in generic formulation development of injectables for regulated markets(US/EU/Japan) from reputed company
Location – Gurgaon
Description :
RESPONSIBILITIES:
- Planning, coordination and execution of product development activity for global markets.
- Evaluation of literature and patents related to products under development.
- Planning of stability studies and reviewing of development and stability data.
- Compilation of Technology Transfer Dossier related documents.
- Scale-up and technology transfer of products to manufacturing locations.
TECHNICAL EXPERIENCE:
- Handling of Para IV ANDA products for US market.
- Good understanding of regulatory requirements of global markets.
- Good understanding of Patent and IPR strategies.
- Execution of exhibit batches and technology transfers to manufacturing locations.
PERSONAL ATTRIBUTES:
- Commitment, ownership, integrity, adherence to time lines.
- Should have good planning and organizing capabilities.
- Should be self motivated and having positive attitude.
- Should have good drafting and communication skills.
- Should have good team spirit.
