TITLE: Formulation Scientist I and II
Essential Job Function: Perform formulation development activities (including processing of small scale batches) under the direction of formulation project leaders. Perform physical and chemical characterization of raw materials and dosage forms. Maintain project and laboratory records. Work on projects ranging from formulation development for early phase clinical studies (bench scale) through scale up to a commercially viable formulation and process in collaboration with project leaders, process scientists and technicians.
General Information:. Minimum of B.S. in Pharmacy, chemical engineering, chemistry or related field (M.S. preferable) with 2-3 years in the pharmaceutical industry including direct experience with solid oral dosage forms. Good verbal and written communication skills. Good mechanical and mathematical skills. Ability and willingness to perform hands-on work including operating pharmaceutical processing equipment. Enthusiasm and willingness to learn. Familiarity with cGMP and regulatory requirements. Knowledge of MS word and Excel.
This position is classified as a “safety sensitive” position and is subject to random drug testing.
Responsibilities to include, but not limited to:
- Perform experiments required for the projects (bench top preformulation and formulation work).
- Prepare experimental formulation prototypes utilizing solid dosage form processing equipment (fluid bed processing, tableting, encapsulation).
- Manufacture clinical supplies.
- Clearly document and summarize experiments in a laboratory notebook in a timely matter.
- Execute stability protocols in coordination with analytical group.
- Perform scanning electron microscopy or additional physical evaluation of raw materials and dosage forms.
- Perform physicochemical characterization of raw materials and dosage forms, including performing excipient compatibility studies in collaboration with the analytical group.
- Write and execute experimental plan and protocols, and batch records, as required.
- Assist in sourcing and evaluating of raw materials. Maintain inventory control of feasibility materials.
- Participate in process demonstrations for training seminars..
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