Associate, R&D/Formulation Scientist
Shreeveport, LA 19342
- Identify the Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes and Critical Process Parameters to arrive at robust formulation design and manufacturing process.
- Perform all experiments required and develop generic drug products with stable and bioequivalent composition, and robust manufacturing process.
- Work with Biopharmaceutics and Analytical R&D teams to design predictive in vitro methods for achieving bioequivalence.
- Perform all documentation required for product development, ANDA filing and address deficiencies from regulatory agencies.
- Good knowledge of pre-formulation, formulation & manufacturing process development.
- Experience in unit operations such as granulation, blending, compression, coating and fluid bed processing.
- Experience in developing extended release products; handling controlled substances is a plus.
- Experience in handling scale up and exhibit batches in CGMP environment.
- Basic knowledge in analytical techniques.
- Basic knowledge in biopharmaceutics & pharmacokinetics and bioequivalence studies.
- Good knowledge in requirements of FDA for ANDA filing and approval.
- Should be able to perform in dynamic environment, and collaborate within team and cross-functional teams.
- Good communication (written & verbal), interpersonal, and organization skills
- Good computer skills including experience with MS Office Suite.