Process Development Scientist - Analytical Methods

Amgen; Cambridge (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen is seeking a Process Development Associate to support manufacturing process development. You will conduct experiments, analyze data, and document results while collaborating with senior scientists and engineers to implement process improvements.

The role emphasizes analytical method development, GMP-compliant documentation, and active participation in cross-functional teams to advance product development and regulatory submissions.

Qualifications

• Experience with protein assays, ELISA, and protein interactions.
• Molecular biology experience (qPCR, DNA isolation).
• GDP documentation and Electronic Laboratory Notebook systems.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Perform analytical testing to evaluate residual process impurities in drug substances and intermediates.
• Prepare technical reports for investigations, characterizations, and regulatory submissions.
• Document laboratory activities according to GMP guidelines.
• Generate and interpret analytical data to support product development investigations and regulatory submissions.
• Maintain awareness of developments in analytical development and regulatory activities.
• Support method development, qualification, and transfer projects.
• Participate in cross-functional analytical development teams with documentation.

Skills

Protein assays

Molecular biology

Communication

Innovation

Social skills

Data analysis

Education

Bachelor’s degree / Associate’s degree / high school + scientific experience

Tools

JMP

R

SAS

GraphPad

Microsoft Office (Word, PowerPoint, Excel)

Job description

Amgen is seeking a Process Development Associate to support manufacturing process development. You will conduct experiments, analyze data, and document results while collaborating with senior scientists and engineers to implement process improvements.

The role emphasizes analytical method development, GMP-compliant documentation, and active participation in cross-functional teams to advance product development and regulatory submissions.