Process Development Sr Scientist

Role Summary

Process Development Sr Scientist within the Pre-Pivotal Drug Product, Synthetics Enabling Technologies (SET) team. You will support early formulation development and physicochemical characterization with a focus on chemical stability to advance preclinical and clinical programs. You will contribute to regulatory filings and Amgen’s intellectual property while representing SET on Discovery Research and Early Development teams. This role emphasizes collaboration, problem-solving, and applying automation and data science to enhance laboratory workflows.

Responsibilities

• Evaluation of drug candidate stability, structural elucidation, and identification of degradation pathways.
• Synthetics molecule assessment (developability 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 CMC sections in regulatory documents.
• Apply continuous improvement practices to enhance overall laboratory efficiency.

Qualifications

• Required: Bachelor's degree and 5 years of scientific experience, or Master's degree and 3 years of scientific experience, or Doctorate degree (PhD, PharmD, or MD) with relevant post-doc where applicable.
• Preferred: Doctorate Degree (PhD or PharmD) 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.
• Preferred: Strong understanding in Mass Spectrometry or Liquid Chromatography Mass Spectrometry (LCMS).
• Preferred: 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.).
• Preferred: Experience in chemical kinetics, pharmacokinetics or biopharmaceutical modeling.
• Preferred: Ability to take initiative, work independently, and be flexible in responsibilities.
• Preferred: Experience in liquid dosage forms (e.g. drug-in-bottle, parenteral, inhalation, topical) for synthetics.
• Preferred: Ability to integrate automation solutions and data science approaches to enhance laboratory workflows.
• Preferred: Proficiency with instrumentation platforms and client-server data management systems.
• Preferred: Experience applying statistical analysis and data visualization tools.
• Preferred: Problem solver with a proactive demeanor and ability to collaborate and work in a cross-functional/multidisciplinary environment.
• Preferred: Excellent written, verbal, and presentation skills.