Overview
A Senior Executive in Excipient Research and Development (R&D) plays a pivotal role in pharmaceutical companies by leading the development, evaluation, and optimization of excipients used in drug formulations.
Key Responsibilities
Lead and oversee the development of new excipients and the optimization of existing ones.
Conduct pre-formulation studies, compatibility studies, and stability studies.
Manage R&D projects from conceptualization to completion, ensuring timely delivery of milestones.
Coordinate cross-functional teams including formulation scientists, analytical chemists, and production engineers.
Ensure all R&D activities comply with regulatory standards (FDA, EMA, ICH guidelines).
Prepare and review technical documentation for regulatory submissions.
Implement quality control procedures and conduct risk assessments.
Collaborate with quality assurance teams to resolve issues related to excipient performance.
Qualifications
Education: Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
Experience: Minimum of 5-7 years in excipient R&D or related pharmaceutical research.
Strong knowledge of excipient functionalities and their impact on drug formulation.
Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and chromatography.
Excellent project management and organizational skills.
