Associate, R&D/Formulation Scientist

3/30/21

Shreeveport, LA 19342

1204

BS Chemistry

FullTimeRegular

Key responsibilities:

  • 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.

Requirements:

  • 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.
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