Process Development Senior Scientist
Amgen
August 21, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Senior Scientist
What You Will Do
- Responsible for development, characterization, scale-up, and support of drug substance processes to enable commercial advancement of programs from Phase II/III to marketing application.
- Work in a coordinated group with cell culture and purification scientists to advance multiple modalities (antibodies, oncolytic viruses, bispecifics, siRNAs).
- Apply platform approaches and problem-solving to tackle drug substance challenges and build robust processes with efficient experimentation.
- Drive innovation/out-of-the-box thinking to contribute to technology development.
- Expand skills in cell culture and purification.
- Collaborate cross-functionally with analytical and drug product representatives to deliver phase-appropriate drug substance manufacturing processes.
- Deliver processes amenable to cGMP operation and execute in a cGMP manufacturing environment.
- Author or direct technical reports/CMC regulatory submissions (may require minimal editing).
Basic Qualifications
- Doctorate degree
- OR Master’s degree + 2 years of Life Sciences experience
- OR Bachelor’s degree + 4 years of Life Sciences experience
Preferred Qualifications
- Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing (or relevant industry experience).
- Bioreactor process development or cell line development experience.
- Knowledge of bioreactor technologies and ability to develop new approaches.
- Understanding protein characteristics/critical attributes; product/process control strategies.
- Independently resolve issues in cell culture/harvest; implement scientific projects.
- Strong written/verbal technical communication.
- Self-starter with interpersonal and organizational skills.
- Leadership experience; inspire/lead scientists to meet timelines.
- Peer-reviewed publication record.
- Cross-functional team experience.
- Familiarity with design of experiments (DoE) and statistical analysis.
- Knowledge of license application and drug development process.
- Exposure to cGMP manufacturing and CMC regulatory submission components.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until a sufficient number is received or a candidate is selected.
What You Will Do
- Responsible for development, characterization, scale-up, and support of drug substance processes to enable commercial advancement of programs from Phase II/III to marketing application.
- Work in a coordinated group with cell culture and purification scientists to advance multiple modalities (antibodies, oncolytic viruses, bispecifics, siRNAs).
- Apply platform approaches and problem-solving to tackle drug substance challenges and build robust processes with efficient experimentation.
- Drive innovation/out-of-the-box thinking to contribute to technology development.
- Expand skills in cell culture and purification.
- Collaborate cross-functionally with analytical and drug product representatives to deliver phase-appropriate drug substance manufacturing processes.
- Deliver processes amenable to cGMP operation and execute in a cGMP manufacturing environment.
- Author or direct technical reports/CMC regulatory submissions (may require minimal editing).
Basic Qualifications
- Doctorate degree
- OR Master’s degree + 2 years of Life Sciences experience
- OR Bachelor’s degree + 4 years of Life Sciences experience
Preferred Qualifications
- Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing (or relevant industry experience).
- Bioreactor process development or cell line development experience.
- Knowledge of bioreactor technologies and ability to develop new approaches.
- Understanding protein characteristics/critical attributes; product/process control strategies.
- Independently resolve issues in cell culture/harvest; implement scientific projects.
- Strong written/verbal technical communication.
- Self-starter with interpersonal and organizational skills.
- Leadership experience; inspire/lead scientists to meet timelines.
- Peer-reviewed publication record.
- Cross-functional team experience.
- Familiarity with design of experiments (DoE) and statistical analysis.
- Knowledge of license application and drug development process.
- Exposure to cGMP manufacturing and CMC regulatory submission components.
Application Instructions
- Apply via careers.amgen.com. No application deadline; applications accepted until a sufficient number is received or a candidate is selected.