We are currently partnered with a leading Biopharma committed to developing innovative therapeutics to address diseases with high unmet medical need.
They are extremely well-funded and their flagship program has the potential to be a first-in-class therapeutic for multiple indications. They are looking to bring on a Principal Scientist, CMC (Pre-Formulation) to bridge upcoming clinical assets from discovery to CMC.
Responsibilities :
Lead preclinical formulation development in collaboration with Discovery, Toxicology, and CMC teams, utilizing preformulation / characterization data to guide formulation decisions.
Author formulation development reports and manage internal documentation, ensuring compliance with regulatory and organizational standards.
Engage and manage external resources (e.g., CROs) and maintain up-to-date experimental records in an Electronic Lab Notebook.
Qualifications :
PhD or Masters in a relevant field (e.g., chemistry, pharmaceutics) with 10+ years’ pharmaceutical industry experience in small molecule formulation development.
Expertise in injectables, oral, and intra-peritoneal formulations; experience with Solid State Characterization techniques - XRPD, Polymorphism, PSD, DVS, DSC
Ability to support Analytical testing – hands on experience with HPLC, LCMS etc.