Bristol-Myers Squibb Company

Principal Scientist

New Brunswick, NJ, US
Nov 12, 2018
Required Education
Position Type
Full time
Job Responsibilities:

As Principle Scientist you will be responsible for developing and executing model based strategies for drug product development in preclinical and clinical programs. He/She will design and develop physiologically based pharmacokinetic absorption models to identify biopharmaceutics performance attributes that are critical for successful formulation and development of oral solid dosage forms. The position also requires developing integrated biopharmaceutics modeling and simulation packages for regulatory interactions and dossier submissions.

The successful candidate will be knowledgeable in pharmacokinetics, ADME, drug product formulation, materials science, biorelevant analytical methods, and regulatory guidance documents for oral dosage forms. This includes a proficient understanding of bioavailability/bioequivalence, formulation technologies (e.g. immediate release and controlled release tablets), materials characterization (e.g. physical forms, solubility analysis, etc.), as well as the numerous physiological factors important to drug absorption and pharmacokinetics. Additionally, the candidate will demonstrate ability to interpret and analyze clinical/pre-clinical pharmacokinetic data and have demonstrated experience with common software platforms (e.g. Phoenix WinNonlin, GastroPlus, simCYP). The candidate will be proficient in applying oral bioavailability enhancement formulation strategies (e.g. amorphous, solubilized, and other novel delivery systems) and establishing performance targets based on modeling and simulation.

This candidate must work in a matrix environment to apply modeling/simulation, pharmaceutics, ADME, chemistry principles and technologies to deliver robust products to patients. The successful candidate will effectively manage development projects with minimal supervision and provide independent interactions with multiple functional groups including discovery, clinical pharmacology, regulatory, and toxicology.

Job Requirements:

This position requires a Ph.D. in Pharmaceutics or related scientific disciplines with more than eight years of experience in biopharmaceutics and pharmacokinetic absorption modeling and simulation. In depth understanding of PBPK modeling software such as GastroPlus and SimCYP are a necessity. The candidate should have a demonstrated record of publications and presentations that apply mechanistic biopharmaceutics modeling. Hands on experience in NCE development, preformulation, and formulation supporting clinical progression of an asset is desired. The candidate must be innovative and possess excellent verbal and written communication skills as well as the ability to work effectively as an individual contributor in a team environment.