Process Development Principal Scientist

Process Development Principal Scientist We are seeking a Principal Scientist for Process Development focused on synthetic small molecules and peptides. Responsibilities Lead analytical method development, validation, and troubleshooting for drug substances, drug products, and in‑process testing for synthetic small molecules and/or synthetic peptides. Define analytical control strategies and implement methodologies for development of late‑phase clinical programs. Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives. Lead and mentor a group of analysts supporting process development. Provide career development guidance to team members. Provide concise summaries to cross‑functional leadership for endorsement of key decisions. Oversee activities at contract manufacturing and testing sites. Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Address analytical and product quality inquiries from health authorities. Supervise direct reports. Qualifications Requirements: PhD degree or foreign equivalent in analytical chemistry, chemistry, or related field, and a minimum of 3 years of experience in the job offered or in a process development‑related occupation. Position requires 3 years of experience in the following: Mass spectrometry knowledge, including ionization techniques, platform configuration for vendors such as Waters, Thermo Fisher, and Agilent, and gas‑phase ion chemistry for structural elucidation. Sample preparation, including liquid‑liquid extraction and solid‑phase microextraction for qualitative and quantitative analysis of small and large molecules. Analytical techniques such as FT‑IR (Fourier‑transform infrared spectroscopy), NMR (nuclear magnetic resonance), and UV (ultraviolet‑visible spectroscopy). Chromatography and related separation techniques, including RP‑HPLC (reversed‑phase high‑performance liquid chromatography) and GC (gas chromatography). High‑throughput analysis of multidimensional mass spectrometry‑based data, statistical analysis implementation, and interpretation of statistical results. Software applications, including ChemDraw, Xcalibur, or ChemStation, and programming languages for data processing such as Python or Matlab. Compensation & Benefits Annual salary range: $148,363.00–$171,657.00 per year. The position is Full Time. Stock‑based long‑term incentives. Retirement plan with generous company contributions. Group medical, dental, and vision coverage. Life and disability insurance. Flexible spending accounts. Discretionary annual bonus program. Time‑off plans, including paid holidays and vacation. Flexible work models, including remote and hybrid arrangements where possible. EEO Statement Amgen is an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. Amgen will provide reasonable accommodation to individuals with disabilities to participate in the application or interview process and to perform essential job functions. #J-18808-Ljbffr Amgen Inc. (IR)