Process Development Senior Scientist
Amgen
August 29, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Senior Scientist
What You Will Do
- Develop, characterize, scale-up, and support drug substance processes to advance programs from Phase II/III clinical trials to marketing application.
- Collaborate in an integrated group of cell culture and purification scientists to advance multiple biologic modalities (e.g., antibodies, oncolytic viruses, bispecifics, siRNAs).
- Apply platform approaches and problem-solving skills to build robust processes with efficient experimentation.
- Drive innovation and contribute to technology development.
- Expand purification and cell culture skills to support the integrated group.
- 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 authorship of) technical reports and CMC regulatory submissions with minimal additional editing.
Basic Qualifications
- Doctorate degree
OR
- Master’s degree and 2 years of Life Sciences experience
OR
- Bachelor’s degree and 4 years of Life Sciences experience
Preferred Qualifications
- Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences.
- Track record troubleshooting protein drug substance purification (process development preferred).
- Hands-on protein chromatography experience (affinity, ion exchange, hydrophobic interaction).
- Filtration operations experience (ultrafiltration/diafiltration).
- Understanding protein characteristics/critical attributes for product/process control strategies.
- Independently identify/develop/implement scientific solutions.
- Self-starter with strong interpersonal and organizational skills.
- Leadership experience encouraging/leading scientists.
- Peer-reviewed publication record.
- Experience in diverse cross-functional teams.
- Familiarity with DOE and statistical analysis.
- Knowledge of license applications and drug development process.
- Exposure to cGMP manufacturing and CMC regulatory submissions.
Application Instructions
- Apply at careers.amgen.com; no application deadline is listed, and applications are accepted until a sufficient number is received or a candidate is selected.
What You Will Do
- Develop, characterize, scale-up, and support drug substance processes to advance programs from Phase II/III clinical trials to marketing application.
- Collaborate in an integrated group of cell culture and purification scientists to advance multiple biologic modalities (e.g., antibodies, oncolytic viruses, bispecifics, siRNAs).
- Apply platform approaches and problem-solving skills to build robust processes with efficient experimentation.
- Drive innovation and contribute to technology development.
- Expand purification and cell culture skills to support the integrated group.
- 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 authorship of) technical reports and CMC regulatory submissions with minimal additional editing.
Basic Qualifications
- Doctorate degree
OR
- Master’s degree and 2 years of Life Sciences experience
OR
- Bachelor’s degree and 4 years of Life Sciences experience
Preferred Qualifications
- Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences.
- Track record troubleshooting protein drug substance purification (process development preferred).
- Hands-on protein chromatography experience (affinity, ion exchange, hydrophobic interaction).
- Filtration operations experience (ultrafiltration/diafiltration).
- Understanding protein characteristics/critical attributes for product/process control strategies.
- Independently identify/develop/implement scientific solutions.
- Self-starter with strong interpersonal and organizational skills.
- Leadership experience encouraging/leading scientists.
- Peer-reviewed publication record.
- Experience in diverse cross-functional teams.
- Familiarity with DOE and statistical analysis.
- Knowledge of license applications and drug development process.
- Exposure to cGMP manufacturing and CMC regulatory submissions.
Application Instructions
- Apply at careers.amgen.com; no application deadline is listed, and applications are accepted until a sufficient number is received or a candidate is selected.