Associate, R&D/Formulation Scientist

Job Description

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.