Principal Formulation Chemist
Principal Formulation Chemists lead the design and development of pharmaceutical formulations that optimize the delivery, stability, and bioavailability of active pharmaceutical ingredients (APIs). They oversee pre-formulation studies, develop new drug delivery systems, and guide products through scale-up and tech transfer.
Key responsibilities:
Designing dosage forms – Including tablets, capsules, suspensions, injectables, or inhalables tailored to the physicochemical properties of the API.
Conducting compatibility and stability studies – Using analytical methods like HPLC, DSC, and particle sizing to evaluate formulation performance over time.
Guiding scale-up and GMP manufacturing – Working with process engineers and quality teams to ensure reproducibility and regulatory readiness.
Leading formulation strategy – Including QbD approaches, DoE experimental planning, and documentation for regulatory submissions (e.g. IND, NDA, MA).
Mentoring formulation scientists – Providing scientific and strategic leadership to support R&D milestones and client projects.
This role typically requires experience with excipients, granulation, lyophilization, and other pharmaceutical manufacturing techniques, along with strong knowledge of ICH, FDA, and EMA expectations.