Process Development Senior Scientist

About This Role

Join the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team to support early formulation development and physicochemical characterization, focusing on chemical stability for preclinical and clinical development programs. This role involves contributing to regulatory filings and Amgen's intellectual property.

Responsibilities

• Evaluate drug candidate stability, structural elucidation, and identify degradation pathways
• Perform synthetics molecule assessment (developability assessment) and preclinical formulation support
• Support lead optimization and form selection to meet the target product profile
• Apply 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

Requirements

• Bachelors degree and 5 years of Scientific experience OR Masters degree and 3 years of Scientific experience OR Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Qualifications

• Bachelors degree in a scientific field and 5 years of Scientific experience OR Masters degree in a scientific field and 3 years of Scientific experience OR Doctorate degree (PhD OR PharmD OR MD) and relevant post-doc where applicable
• 3+ years of scientific experience with a Master's degree, or 5+ years with a Bachelor's, or Doctorate degree with relevant post-doc experience.

Nice to Have

• Doctorate Degree (PhD OR PharmD) with 2+ years of post-PhD experience in Pharmaceutics, Pharmacy, Chemistry or related field
• Experience in synthetic, mechanistic, or physical organic chemistry, and structural elucidation 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.)
• Experience in chemical kinetics, pharmacokinetics or biopharmaceutical modeling
• Experience in liquid dosage forms (e.g. drug-in-bottle, parenteral, inhalation, topical) for synthetics
• 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
• Ability to take initiative, work independently, and be flexible in responsibilities
• Excellent written, verbal, and presentation skills

Skills

* Required skills

Benefits