Thousand Oaks, CA30+ days ago
Basic Qualifications: Doctorate degree Or Master's degree and 2 years of Operations or Process Development experience Or Bachelor's degree and 4 years of Operations or Process Development experience Or Associate's degree and 8 years of Operations or Process Development experience Or High school diploma / GED and 10 years of Operations or Process Development experience Preferred Qualifications: M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry Familiarity with aseptic processing, drug product manufacturing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools Knowledge of bringing new products to market, across various dosage forms and delivery systems Knowledge of associated GMP/Device documentation and regulatory filings Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible.