Design and perform formulations and processes for new drug products, focusing on oral solids, powders for constitution, solutions, and suspensions for clinical trials, ANDA, and NDA projects. Develop new products utilizing existing and emerging technologies available within the industry, from pre formulation through the manufacturing stage. Use experimental design to rapidly optimize formulation composition and in-process specifications. Evaluate product testing results and recommend next steps for continued development until the product formulation and process are finalized. Present product development progress to senior management and project teams. Write Current Good Manufacturing Practices (cGMP) manufacturing batch records, stability study protocols, in-process and finished product specifications, and product development reports. Manufacture development, optimization, scale-up, and submission batches. Troubleshoot formulation issues arising during R&D development, scale-up, and production. Conduct and manage development projects with managerial guidance, ensuring the successful scale-up of new products and/or processes. Communicate effectively with cross-functional teams, including Analytical Development, Quality, PK, Regulatory Affairs, and Legal. Attend SOP, safety, and scientific training to remain current with cGMP regulations, safety standards, and development technologies.

Requirements:

Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a similar field.

Six years of experience in pharmaceutics, solid dosage formulation development, drug delivery technologies, processing technologies, or a related field.

Experience in pharmaceutical operations (granulation, tableting, particle coating for controlled or targeted-release applications, encapsulation, fluid bed operations, suspensions, solutions, or microencapsulation).

Experience with cGMP, FDA, DEA, and OSHA regulations.

Knowledge of PK-PD relationships and IV/IV correlations.

Adare Pharmaceuticals, Inc jobs

Senior Formulations Scientist I