Process Development Sr Scientist - Thousand Oaks, CA

Overview

In this dynamic role you will join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team and support early formulation development and physicochemical characterization with a focus on chemical stability to advance preclinical and clinical development programs. In doing so you will contribute to regulatory filings and to Amgen’s intellectual property. In addition, you will have the opportunity to support activities and represent SET on both Discovery Research and Early Development teams, providing functional area expertise.

• Evaluation of drug candidate stability, structural elucidation, and identification of degradation pathways.
• Synthetics molecule assessment (develop ability assessment) and preclinical formulation support.
• Supporting lead optimization and form selection to meet the target product profile.
• Application of in silico and in vitro models to support molecule and biopharmaceutical assessments and identify development strategies.
• Coordinate with team members and external partners to meet defined tasks and project milestones.
• Support the project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
• Apply continuous improvement practices to enhance overall laboratory efficiency.

• We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications.

• Bachelor’s degree and 5 years of scientific experience OR Master’s degree and 3 years of scientific experience OR Doctorate degree (PhD) OR Pharm
  
  D OR MD [and relevant post-doc where applicable]

• Doctorate Degree (PhD OR Pharm
  
  D) with 2+ years of post-PhD experience in Pharmaceutics, Pharmacy, Chemistry or related field preferred
• Experience in synthetic, mechanistic, or physical organic chemistry, and structural elucidation is informed by knowledge of organic chemistry
• Strong understanding in Mass Spectrometry or Liquid Chromatography Mass Spectrometry (LCMS)
• 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.) is beneficial
• Experience in chemical kinetics, pharmacokinetics or biopharmaceutical modeling is beneficial
• Ability to take initiative, work independently, and be flexible in responsibilities
• Experience in liquid dosage forms (e.g. drug-in-bottle, parenteral, inhalation, topical) for synthetics
• An ability to integrate automation solutions and data science approaches to enhance laboratory workflows
• Proficiency with instrumentation platforms and client-server data management systems
• Experience applying statistical analysis and data visualization tools
• Problem solver with a proactive demeanor and ability to collaborate and work in a cross functional/multidisciplinary environment
• Excellent written, verbal, and presentation skills – ability to distill, craft and present key messages relative to diverse audience requirements

City:
Thousand Oaks

State:
California

• Job Code:
  Pharmaceutical
• Affiliate Sponsor:
  Amgen
• Salary Range: >$100,000