Process Development Principal Scientist, Newbury Park

Process Development Principal Scientist

Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Duties: Lead analytical method development, validation and trouble-shooting for drug substances and drug products and in-process testing for synthetic small molecules and/or synthetic peptide testing and characterization. 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 in supporting process development. Provide career development guidance to the team members. Provide concise summary 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. Supervises direct reports.Requirements: PHD degree or (foreign equivalent) in analytical chemistry, chemistry, or related field&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 in mechanism of different ionization techniques, configuration of mass spectrometry platforms by different vendors including Waters, Thermo Fisher, or 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 both small molecules and large molecules; Analytical techniques including 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 in processing multidimensional mass spectrometry-based data and implementing statistical analysis and interpreting statistical results; andSoftware applications including ChemDraw, Xcalibur, or ChemStation and programming language for data processing including Python or Matlab.. Apply now and make a lasting impact with the Amgen team. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.Amgen is an Equal Opportunity employer and will 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 applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.