Support in the development and optimization of drug formulations and manufacturing processes for topical, transdermal, nasal, and injectable products. Responsibilities include: Designing and conducting experiments for formulation and process development; Developing prototype formulations and performing stability studies; Evaluating raw materials and experimental batches to ensure robust manufacturing practices; Coordinating analytical testing and establishing appropriate controls; Managing pilot-scale and submission batch production, including scale-up activities; Overseeing exhibit batch manufacturing for ANDA submissions and clinical studies; Maintaining and calibrating R&D instruments and equipment; Preparing technical documentation, including master formulas, SOPs, stability reports, product development reports, and regulatory submission documents; Ensuring compliance with cGMP, cGLP, FDA, and ICH guidelines; Performing risk assessments and preparing scientific reports (e.g., Nitrosamine, elemental impurities, residual solvents). Supporting regulatory filings (ANDA/NDA) and contributing to CMC sections. Collaborating with cross-functional teams (Analytical R&D, Quality Assurance, Regulatory Affairs, Clinical, Manufacturing). Applying scientific reasoning and data analysis to support decision-making and project management. Staying current with new technologies, methods, and regulatory requirements. Applicant must have a Master's degree in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a closely related field. One (1) year of pharmaceutical formulation development experience. Experience must include topical, transdermal, nasal, or injectable formulation development. Experience with new and/or generic drug product development. Full understanding of FDA regulations, ANDA, IND/NDA processes, and Good Manufacturing Practices is required. Ability to perform pharmaceutical calculations. Experience with critical process parameters (CPP) and critical quality attributes (CQAs) for topical formulations. Knowledge of rheology concepts (viscosity, yield stress, flow curve) and preparation of pharmaceutical development reports (PDR). Experience with CMC sections of ANDA/NDA filings is required. Must have proficiency in technical writing and documentation per cGMP/cGLP standards.
| Location | Denville, NJ |