Analytical Process Development Specialist

Amgen Inc.; Cambridge (MA); On-site; USD 75,000 - 101,000; Full time

Job summary

Amgen Inc. in Cambridge, MA, is seeking a Process Development Associate to support manufacturing process development.

You will conduct experiments, analyze data, and document results under GMP guidelines, collaborating with senior scientists to implement improvements. The role requires a Bachelor's or equivalent, hands-on experience with protein assays (ELISA) and molecular biology methods (qPCR, DNA isolation), and proficiency with data analysis tools.

Qualifications

• Bachelor's degree or higher is required; other paths accepted with demonstrated scientific experience.
• Associate's degree plus 2 years of scientific experience is acceptable.
• High school diploma with 4 years of scientific experience is acceptable.
• Experience with GMP and regulatory filings (IND, BLA, NDA) is preferred.

Responsibilities

• Develop and implement analytical methods for impurity release testing.
• Perform analytical testing to evaluate residual process impurities in drug substances.
• Prepare technical reports for investigations, characterisation and regulatory submissions.
• Document laboratory activities according to GMP guidelines.
• Generate, analyze and interpret analytical data to support development and regulatory needs.

Skills

Protein assays

ELISA

qPCR

DNA isolation

GMP documentation

Regulatory filings

Data analysis

Office software

Education

Bachelor's degree

Associate's degree

High school diploma

Tools

JMP

R

SAS

GraphPad

Job description

Amgen Inc. in Cambridge, MA, is seeking a Process Development Associate to support manufacturing process development.

You will conduct experiments, analyze data, and document results under GMP guidelines, collaborating with senior scientists to implement improvements. The role requires a Bachelor's or equivalent, hands-on experience with protein assays (ELISA) and molecular biology methods (qPCR, DNA isolation), and proficiency with data analysis tools.