Process Development Principal Scientist
Amgen
8 days ago
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Principal Scientist
Duties:
- Lead analytical method development, validation, and trouble-shooting for drug substances and drug products, including in-process testing and analytical testing/characterization for synthetic small molecules and/or synthetic peptides.
- Define analytical control strategies and implement methodologies for development of late phase clinical programs.
- Collaborate with drug substance and drug product process development colleagues to achieve project objectives.
- Lead and mentor a group of analysts; provide career development guidance.
- 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 CMC sections in regulatory documents.
- Address analytical and product quality inquiries from health authorities.
- Supervise direct reports.
Requirements:
- PhD (or foreign equivalent) in analytical chemistry, chemistry, or related field, and 3 years of experience in the job offered or a process development-related occupation.
- 3 years experience in:
- Mass spectrometry (ionization techniques, vendor platform configuration including Waters/Thermo Fisher/Agilent, gas-phase ion chemistry).
- Sample preparation (liquid-liquid extraction; solid phase microextraction) for small and large molecules.
- Analytical techniques: FT-IR, NMR, UV-Vis.
- Chromatography/separation: RP-HPLC and GC.
- High-throughput analysis of multidimensional mass spectrometry data; statistical analysis and interpretation.
- Software/programming: ChemDraw, Xcalibur, ChemStation; Python or Matlab.
Application:
- Apply via https://careers.amgen.com/en/search-jobs and search for job # R-243910.
Benefits (as listed): stock; retirement; medical; life and disability insurance; annual bonus or other incentive compensation; comprehensive employee benefits package; stock-based long-term incentives; time-off plans; flexible remote/hybrid models (where possible).
Duties:
- Lead analytical method development, validation, and trouble-shooting for drug substances and drug products, including in-process testing and analytical testing/characterization for synthetic small molecules and/or synthetic peptides.
- Define analytical control strategies and implement methodologies for development of late phase clinical programs.
- Collaborate with drug substance and drug product process development colleagues to achieve project objectives.
- Lead and mentor a group of analysts; provide career development guidance.
- 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 CMC sections in regulatory documents.
- Address analytical and product quality inquiries from health authorities.
- Supervise direct reports.
Requirements:
- PhD (or foreign equivalent) in analytical chemistry, chemistry, or related field, and 3 years of experience in the job offered or a process development-related occupation.
- 3 years experience in:
- Mass spectrometry (ionization techniques, vendor platform configuration including Waters/Thermo Fisher/Agilent, gas-phase ion chemistry).
- Sample preparation (liquid-liquid extraction; solid phase microextraction) for small and large molecules.
- Analytical techniques: FT-IR, NMR, UV-Vis.
- Chromatography/separation: RP-HPLC and GC.
- High-throughput analysis of multidimensional mass spectrometry data; statistical analysis and interpretation.
- Software/programming: ChemDraw, Xcalibur, ChemStation; Python or Matlab.
Application:
- Apply via https://careers.amgen.com/en/search-jobs and search for job # R-243910.
Benefits (as listed): stock; retirement; medical; life and disability insurance; annual bonus or other incentive compensation; comprehensive employee benefits package; stock-based long-term incentives; time-off plans; flexible remote/hybrid models (where possible).