Analytical Sr Scientist
Amgen Inc
Amgen seeks an Analytical Senior Scientist to develop analytical strategies and methodologies supporting synthetic drug manufacturing and clinical programs. The role involves collaborating with chemistry and formulation teams, managing contract testing sites, and potentially leading a small scientific group. Candidates should hold a PhD in analytical or organic chemistry with pharmaceutical industry experience in method development and characterization.
Responsibilities
- Develop and implement analytical control strategies and methodologies for clinical development programs
- Apply platform knowledge to advance analytical practices from early studies through regulatory applications
- Collaborate with process development and formulation teams on drug substance and product characterization
- Oversee analytical activities and technical transfer at external contract manufacturing sites
- May lead and mentor a small team of analytical scientists
Requirements
- PhD, PharmD, or MD; or Master's degree with 3+ years scientific experience; or Bachelor's degree with 5+ years scientific experience
- Expertise in analytical chemistry techniques including HPLC, UPLC, mass spectrometry, NMR, and solid-state characterization
- Experience developing and validating analytical methods for pharmaceutical drug substances and products
- Knowledge of USP monographs, ICH/FDA guidance, GLP and GMP requirements
- Strong technical writing and cross-functional communication abilities
- Experience managing analytical work at contract manufacturing organizations
Vacancy posted a month ago
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