Process Development Scientist

Role Summary

Process Development Scientist (Attribute Sciences). Join Amgen’s mission to serve patients and contribute to the research, development, and manufacturing of innovative medicines in four therapeutic areas. Collaborate across a global network to identify and address unknown or unexpected materials observed during manufacturing and development, applying advanced analytical tools to ensure cGMP quality standards.

Responsibilities

• Support microanalytical investigations by generating and analyzing data, and reporting results of experiments to identify and assess unknown or unexpected materials observed during manufacturing and development activities.
• Collaborate with internal and external partners across a global manufacturing and PD network to determine root cause and corrective actions for unexpected observations.
• Utilize spectroscopic and microscopic analytical tools for forensics investigations with documentation and compliance appropriate for cGMP standards.
• Support a chemo-metric spectroscopy-based analytical method platform; generate and analyze data to ensure monitoring, maintenance, and validation of chemo-metric models used in GMP manufacturing.

Qualifications

• Basic Qualifications:
  • Bachelor’s degree and 4+ years of scientific or operations experience; OR
  • Master’s degree and 2+ years of scientific or operations experience; OR
  • Doctorate degree
• Preferred Qualifications:
  • Advanced degree in Physical Chemistry, Analytical Chemistry, Chemical Engineering, Materials Science or related field
  • Experience with vibrational spectroscopies (FTIR, Raman)
  • Experience with microscopy and microanalytical techniques for materials characterization
  • Ability to critically analyze analytical datasets to influence the investigational process
  • Strong wet chemistry and sample handling knowledge
  • Understanding of multivariate analysis and chemo-metric model training, validation, monitoring, and maintenance
  • Commitment to GDP and cGMP standards
  • Experience in an investigational laboratory within a pharmaceutical or biotechnology company
  • Excellent written and oral communication for documenting and presenting results in a fast-paced, multidisciplinary environment

Skills

• Analytical thinking and data interpretation
• Strong documentation practices and attention to regulatory compliance
• Collaboration across global teams
• Effective communication of complex scientific results

Education

• See Qualifications above for degree expectations (Bachelor’s, Master’s, or Doctorate in relevant field).

Additional Requirements

• None beyond the Qualifications and responsibilities listed.