Process Development Scientist - Drug Product Technology
Within Amgen's Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Thousand Oaks, CA, is seeking a Process Development Scientist. SET is a key Drug Product Technology interface with partners in Process Development, and, Research and Discovery. This individual will have a focus on evaluation of drug candidate stability, degradation pathways, and structural elucidation, in support of SET's key responsibilities which include:
*Synthetics molecule assessment (developability assessment) and preclinical formulation support.
*Biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.
*Early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral).
*Enabling lead optimization and form selection to meet discovery research and process development requirements.
*Solid state characterization support for drug substance and drug product process development for synthetics and biologics programs.
In this role, the scientist will support these activities and represent SET on both Discovery Research and Early/Late Development teams, providing functional area expertise. Finally, the scientist will execute and conduct independent pharmaceutics research.
Doctorate degree or Doctorate completed by October 2018
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
* PhD and 2 years of post-doctoral or industrial experience in Pharmaceutics, Pharmacy, Chemistry or related field.
* Doctorate Degree in one of the following areas: Pharmaceutical Sciences, Pharmaceutical Chemistry, Organic Chemistry, Physical Chemistry, Biochemistry, or a related scientific discipline.
* Experience in synthetic, mechanistic, or physical organic chemistry, and structural elucidation
* Experience in LCMS and NMR
* Experience in preformulation techniques including HPLC analysis, physicochemical evaluation (solubility, pKa and LogP determination, etc.) and solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.)
* Experience in Pharmacokinetic or Biopharmaceutical modeling software
* Experience in physical form screening and selection
* Computer competency and experience, particularly with Microsoft Excel and other data analysis software
* Abilities to take initiative, work independently, and be flexible in responsibilities
* Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment