Analytical Scientist

Responsibilities

• Develop analytical tools and control strategies for synthetic manufacturing processes and products
• Define analytical control strategies and implement methodologies for pivotal phase clinical programs
• Collaborate with drug substance and drug product process development colleagues
• Manage activities at contract manufacturing and testing sites
• Integrate platform and prior product knowledge to advance practices from FIH studies through marketing applications
• Lead and develop small groups of scientists as needed

Requirements

• Doctorate degree OR Master's degree with 2 years of scientific experience OR Bachelor's degree with 4 years of scientific experience
• Experience in analytical method development
• Proficiency with chromatography (HPLC/UPLC), mass spectrometry, NMR, and FTIR
• Strong technical writing skills for authoring methods, specifications, and regulatory documents
• Solid understanding of GLP and GMP requirements

Preferred Qualifications

• Master's degree in Analytical Chemistry, Organic Chemistry, Materials Science, or related engineering field
• Experience in the pharmaceutical or biotech industry regarding process and product development
• Strong understanding of small molecule analysis, structure elucidation, and solid-state characterization
• Experience developing methods for in-process testing, release, and stability testing
• Familiarity with USP monographs and ICH/FDA guidance documents
• Experience in technical transfer to external contract organizations

Benefits

• Comprehensive medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. Since 1980, the company has focused on serving patients living with serious illnesses in therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease.