- Designs formulations and conducts formulation trials by using different pharmaceutical techniques.
- Develops manufacturing processes and makes prototype batches, phase I, II, and III clinical trial materials.
- Leads production of engineering, registration and scale up etc. batches
- Supports technical transfer and validation activities.
- Required to work closely with other functional areas such as Analytical Development, Project Management, Quality and Commercial manufacture as well as with clients to meet the time-lines
- Participates in research and development activities and is accountable for preparation of all technical documents to support our clients submissions for IND, NDA, and ANDA etc.
- Writes formulation trial protocols, manufacturing batch records, packaging batch records and pharmaceutical development reports etc.
- Experience on Design of Experiment (DOE) and Quality by Design (QBD) is preferred.
- A minimum of a Bachelor’s degree in Pharmaceutical, or a related field. Master Degree strongly preferred
- 7 years experience in the area of Pharmaceutical Development; broad knowledge on tablets, capsules, semi-solid and liquid dosage forms.
- Hands on experience on with blending, compression, wet granulation, coating, encapsulation and sustained release formulations etc.