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 for 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 Bachelorís 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.
State or Province