Process Development Principal Scientist

Amgen•Thousand Oaks, CA

1d•$148,363 - $171,657

About The Position

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.

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.
3 years of experience in 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.
3 years of experience in Sample preparation including liquid-liquid extraction and solid phase microextraction for qualitative and quantitative analysis of both small molecules and large molecules.
3 years of experience in Analytical techniques including FT-IR (Fourier-transform infrared spectroscopy), NMR (nuclear magnetic resonance), and UV (ultraviolet–visible spectroscopy).
3 years of experience in Chromatography and related separation techniques including RP-HPLC (reversed phase high-performance liquid chromatography) and GC (gas chromatography).
3 years of experience in High-throughput analysis in processing multidimensional mass spectrometry-based data and implementing statistical analysis and interpreting statistical results.
3 years of experience in Software applications including ChemDraw, Xcalibur, or ChemStation and programming language for data processing including Python or Matlab.

Responsibilities

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.

Benefits

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
flexible spending accounts
discretionary annual bonus program
sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible