Process Development Scientist
The Synthetics Enabling Technology (SET) group within the Drug Product Technologies (DPT) department of Amgen in Cambridge, MA is seeking an enthusiastic, highly motivated, and team-oriented scientist for the position of Process Development Scientist. SET is a key DPT interface with partners in Process Development, Discovery Research, and Translational Sciences, conducting molecule assessment of synthetics, staging molecules, identifying and executing strategies for discovery and early development. Within this space Synthetics Enabling Technologies:
· Provides synthetics molecule assessment (developability assessment) and preclinical formulation support
· Enables lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).
· Utilizes predictive in silico and in vitro models to support molecule and biopharmaceutical assessments to identify development strategies
· Provides early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and conducts technical transfers to support clinical manufacturing (GMP).
In this role, the scientist will support these activities and represent SET on both Discovery Research and Early Development teams, providing functional area expertise. It is expected that this individual will have expertise in enabling formulation development (e.g. lipids, nanoparticles) for high molecular weight and/or low permeability synthetic molecules (i.e. beyond-rule-of-5 compounds). Finally, the scientist will execute and conduct independent pharmaceutics research.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
PhD with 2 years of post-doctoral or industrial experience in Pharmaceutics, Pharmacy, Chemistry or related field.
Experience in enabling formulation development (e.g. lipids, nanoparticles) of high molecular weight and/or low permeability synthetic molecules (i.e. beyond-rule-of-5 compounds) parenteral delivery.
Experience in preformulation techniques including HPLC analysis, physicochemical evaluation (solubility, stability, pKa and LogP determination, etc.) and solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) are required
Experience in Pharmacokinetic or Biopharmaceutical modeling software is a plus.
Experience in physical form screening and selection is a plus.
Experience in mass spectrometry is beneficial.
Experience in automated screening platforms is a plus
Computer competency and experience, particularly with Microsoft Excel and other data analysis software, are essential
A strong conceptual grasp of basic pharmaceutics and general, analytical, and organic chemistry is required
Abilities to take initiative, work independently, and be flexible in responsibilities are strongly desired
Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment are strongly desired.