Analytical Process Development Associate

BioSpace; 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 by conducting experiments, analyzing data, and documenting results. You will work with senior scientists and engineers to implement improvements and ensure compliant documentation.

Responsibilities include method development for impurity release testing, analytical testing of residual impurities, and preparation of technical reports for regulatory submissions.

Qualifications

• Bachelor's degree required; 2+ years with science-related work optional, depending on degree path.
• Experience with protein assays, particularly ELISA, and formats for protein interactions.
• GMP experience and regulatory filings knowledge (IND/BLA/NDA) are a plus.

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, product and impurity characterization, and regulatory submissions.
• Document laboratory activities according to GMP guidelines.
• Generate, analyze, and interpret analytical data to support development investigations and regulatory submissions.
• Keep abreast of analytical development literature and technology.

Skills

ELISA

qPCR

DNA isolation

JMP

R

SAS

GraphPad

GDP documentation

Electronic Lab Notebook

GMP compliance

Regulatory filings (IND/BLA/NDA)

Microsoft Office

Education

Bachelors degree

Associates degree

High school diploma / GED

Tools

Microsoft Office

ELISA

Job description

Amgen is seeking a Process Development Associate to support manufacturing process development by conducting experiments, analyzing data, and documenting results. You will work with senior scientists and engineers to implement improvements and ensure compliant documentation.

Responsibilities include method development for impurity release testing, analytical testing of residual impurities, and preparation of technical reports for regulatory submissions.