Process Development Scientist

Role Summary

Process Development Scientist (Attribute Sciences) at Amgen. Supports microanalytical investigations, analyzes data, and reports results of experiments to identify and assess unknown or unexpected materials observed during manufacturing and development activities. Collaborates with global partners to determine root cause and corrective actions, applying spectroscopic and microscopic analytical tools to ensure compliance with cGMP standards. Supports a chemo-metric spectroscopy-based analytical method platform for continuous monitoring, maintenance, and validation of chemo-metric models used in GMP manufacturing.

Responsibilities

• Generate and analyze data from microanalytical investigations; report results of experiments.
• Identify and assess unknown or unexpected materials observed during commercial or clinical manufacturing and development activities.
• Collaborate with internal and external partners across a global network to determine root cause and corrective actions.
• Apply state-of-the-art spectroscopic and microscopic analytical tools for forensics investigations with appropriate documentation and compliance to meet cGMP standards.
• Support the chemo-metric spectroscopy-based analytical method platform; generate and analyze data to monitor, maintain, and validate chemo-metric models used for testing 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
  • Expertise in vibrational spectroscopies (FTIR, Raman)
  • Experience with microscopy and microanalytical techniques for materials characterization
  • Ability to critically analyze analytical datasets to influence investigational processes
  • Strong wet chemistry and sample handling skills
  • 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 pharma/biotech
  • Excellent written and oral communication skills for documenting and presenting results in a fast-paced, multi-disciplinary environment

Skills

• Microanalytical data generation and analysis
• Spectroscopy (FTIR, Raman) and microscopy
• Multivariate analysis and chemo-metric modeling
• Good Documentation Practices (GDP) and cGMP compliance
• Collaborative, cross-functional communication

Education

• Relevant advanced degrees as specified in Qualifications