The Formulation Scientist is responsible for the development of the final formulation on a project. The Formulation Scientist actively participates in all the phases of the galenical development including the pre-formulation, process development, scale-up and support for the transfer to the pilot plant.
• 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 and clients to ensure timelines are met.
• Participates in research and development activities and is accountable for preparation of all technical documents to support our client’s submissions for IND, NDA, and ANDA etc.
• Writes formulation trial protocols, manufacturing batch records, packaging batch records and pharmaceutical development reports etc.
• Other duties as assigned
• May be required to lift up to 25lbs
• May handle hazardous waste
• Must be able to move about the laboratory and the facility
• Must be able to remain sedentary for periods of time
• Must be able to remain in an upright position for periods of time
• Required to wear personal protective equipment
• A minimum of a Bachelor’s degree in Pharmaceutical, or a related field.
• Master Degree strongly preferred
• 5 years’ experience in the area of Pharmaceutical Development; broad knowledge on tablets, capsules, semi-solid and liquid dosage forms.
• One year experience in the development of solid dosage forms.
• Hand on experience with blending, compression, wet granulation, coating, encapsulation and sustained release formulations etc.
• Experience on Design of Experiment (DOE) and Quality by Design (QBD) is preferred.