By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.
Associate, R&D/Formulation Scientist, Shreveport - LA
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.
Manufacture scale up and exhibit batches required for filing ANDA at manufacturing sites of Dr. Reddy's or external partners.
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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.