We at Amneal India are looking for multiple Formulation & Development Scientists at Ahmedabad.
Designation: Executive/Sr. Executive/Assistant Manager
Total Experience: 4 to 10 Years
Qualification: M. Pharm
Job Location: Ahmedabad
Job Responsibilities - (Peptide & DDCP) :
- Exposure of product development-related activities of injectable products specifically peptide products.
- Basic understanding of characterization/sameness studies for Peptide API and products required for ANDA submission.
- Exposure of development and scaling-up of the manufacturing process of peptide molecule available in different dosage forms like a liquid solution, lyophilized product, etc.
- Good understanding of drug device combination products and regulatory expectations.
- Exposure to preparing and reviewing drug-device combination-related documents like Design history files, Purchasing control, Threshold analysis, Human factor study, etc.
Job Responsibilities- 505(b)2 :
- Exposure of product development-related activities of injectable products specifically 505(b)2 pathway.
- Basic understanding for parenteral products filing via 505(b)2 route.
- Exposure of development and scaling-up of the manufacturing process for 505(b)2 injectable products.
- Good understanding of the development of novel injectable formulation.
Job Responsibilities- (Liposomal) :
- Exposure of product development-related activities of injectable products specifically Liposomal drug delivery products.
- Basic understanding of characterization/sameness studies for Liposomal products required for ANDA submission.
- Exposure of development and scaling-up of the manufacturing process of Liposome.
- Good understanding of Liposomal product characterization.
Candidate must have exposure for US Market
Interested candidates may share their CV at kavitriy@amnealindia.com with the subject line "Application for F&D Injectable"
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