Senior Analytical Scientist — Pharma Process & Method Development

Jobtailor; California (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking an experienced analytical scientist to join a multidisciplinary team of chemists and formulators. You will help develop analytical tools to understand attributes of synthetic manufacturing processes and products.

The role requires leadership in method development, transfer, and validation, with collaboration across drug substance, drug product, and contract sites to ensure robust strategies from FIH through market application.

Qualifications

• PhD/MD/PharmD or equivalent with 3–5+ years in pharma/biotech R&D or development
• Experience in small molecule analysis, structure elucidation and solid-state characterization
• Knowledge of USP/ICH/FDA guidance on analytical method transfer and validation

Responsibilities

• Work with chemists and formulators on analytical tools for understanding attributes of manufacturing processes
• Lead analytical strategies from FIH to marketing applications
• Collaborate with drug substance and drug product development teams
• Manage activities at contract manufacturing and testing sites
• Possibly lead a small team of scientists
• Develop and implement in-process, release and stability testing methods

Skills

Analytical chemistry

Process development

Analytical method transfer

Technical writing

Team collaboration

Education

PhD in Analytical Chemistry

PharmD OR MD

Master’s degree with 3 years of Scientific experience

Bachelor’s degree with 5 years of Scientific experience

Tools

HPLC

UPLC

Mass spectrometry

NMR

UV

FTIR

Job description

Amgen is seeking an experienced analytical scientist to join a multidisciplinary team of chemists and formulators. You will help develop analytical tools to understand attributes of synthetic manufacturing processes and products.

The role requires leadership in method development, transfer, and validation, with collaboration across drug substance, drug product, and contract sites to ensure robust strategies from FIH through market application.