Process Development Senior Associate I

Role Summary

Process Development Senior Associate at Amgen, contributing to drug substance process development within a collaborative team environment. In this role you will support development activities at multiple scales, contributing to continuous improvement and regulatory documentation. The position supports the delivery of medicines through robust experimental execution and data communication.

Responsibilities

• Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors
• Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed
• Document experimental data in lab notebooks
• Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
• Contribute to technology development projects to seek continuous improvement in reliability and efficiency

Qualifications

• Required: Basic Qualifications:
  • High school diploma / GED and 6 years of life sciences industry experience OR
  • Associate’s degree and 4 years of Quality Control experience OR
  • Bachelor’s degree and 2 years of Quality Control experience OR
  • Master’s degree
• Preferred Qualifications:
  • Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry
  • Relevant hands-on lab experience in cell culture or protein purification
  • Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment
  • Experience in Design of Experiments and statistical analysis is a plus
  • Good oral and written communication skills
  • Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members

Education

• Degree requirements align with Basic Qualifications (High school diploma / GED, Associate’s degree, Bachelor’s degree, or Master’s degree as specified).