Process Development Senior Associate
Amgen
9 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Senior Associate
Duties:
- Conduct experiments, analyze results, and implement process improvements to enhance efficiency and product quality.
- Design, develop, and optimize manufacturing processes.
- Collaborate closely with a team of analysts and scientists.
- Develop analytical tools to understand product and process quality attributes for late-phase synthetic small molecule, synthetic peptide, and siRNA programs.
- Use platform and product attribute knowledge to advance products through pivotal clinical phases to marketing authorization.
- Develop, optimize, and execute analytical methods for synthetic small molecules, synthetic peptide, and SiRNA release testing and process characterization.
- Collaborate with drug substance process development to achieve objectives and provide analytical data.
Requirements:
- Master’s degree (or foreign equivalent) in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry, or related field.
- AND completion of a university-level course/research project/internship/thesis OR 1 year experience including:
- Analytical chemistry for small molecules; targeted metabolomics experiments and analysis using ChemStation, MassHunter, or MassAnalyzer.
- Analytical method development (chromatography and mass spectrometry) using U/HPLC, GC, or LC-MS.
- Method qualification and transfer; data analysis and statistical evaluation.
- Instrument troubleshooting across Waters, Agilent, or Sciex.
- GLP-compliant SOP implementation; maintaining a laboratory notebook.
Contact/Application Instructions:
- Apply via https://careers.amgen.com/en/search-jobs and search job # R-243902.
- Job type: Full Time.
Duties:
- Conduct experiments, analyze results, and implement process improvements to enhance efficiency and product quality.
- Design, develop, and optimize manufacturing processes.
- Collaborate closely with a team of analysts and scientists.
- Develop analytical tools to understand product and process quality attributes for late-phase synthetic small molecule, synthetic peptide, and siRNA programs.
- Use platform and product attribute knowledge to advance products through pivotal clinical phases to marketing authorization.
- Develop, optimize, and execute analytical methods for synthetic small molecules, synthetic peptide, and SiRNA release testing and process characterization.
- Collaborate with drug substance process development to achieve objectives and provide analytical data.
Requirements:
- Master’s degree (or foreign equivalent) in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry, or related field.
- AND completion of a university-level course/research project/internship/thesis OR 1 year experience including:
- Analytical chemistry for small molecules; targeted metabolomics experiments and analysis using ChemStation, MassHunter, or MassAnalyzer.
- Analytical method development (chromatography and mass spectrometry) using U/HPLC, GC, or LC-MS.
- Method qualification and transfer; data analysis and statistical evaluation.
- Instrument troubleshooting across Waters, Agilent, or Sciex.
- GLP-compliant SOP implementation; maintaining a laboratory notebook.
Contact/Application Instructions:
- Apply via https://careers.amgen.com/en/search-jobs and search job # R-243902.
- Job type: Full Time.