Process Development Senior Scientist - Pivotal Drug Product Technologies
Amgen
June 24, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Senior Scientist - Pivotal Drug Product Technologies (Cambridge, MA)
What You Will Do
- Work on late-stage drug product formulation and process development for biologics modalities (e.g., monoclonal antibodies, BiTEs, fusion proteins).
Responsibilities
- Conduct process development for pipeline products and support commercial products through lifecycle management.
- Design, plan, complete, and document formulation and process development studies.
- Develop/characterize/implement processes and next-gen technologies; solve technical challenges.
- Use advanced statistical/data analytics to draw conclusions and inform decisions.
- Support clinical/commercial fill/finish via process capability analysis, troubleshooting, root cause analysis, and product impact assessments.
- Author/review technical protocols, reports, product impact assessments, and regulatory sections for IND/marketing submissions.
- Communicate progress to management and cross-functional partners.
- Lead cross-functional initiatives and contribute to process design improvement projects.
- Travel up to 10%.
Basic Qualifications
- Doctorate OR Master’s + 3 years OR Bachelor’s + 5 years scientific experience.
Preferred Qualifications
- Advanced degree in relevant engineering/science/pharmaceutics.
- Biopharma/biologics development & manufacturing; formulation, fill-finish, tech transfer, and statistical DoE/analysis.
- Experience with formulation/drug product characterization; scale down/up model development.
- Protein stability/process stress understanding.
- Statistical software (SAS/JMP/Minitab), critical thinking, strong project management and attention to detail; cross-functional collaboration.
Benefits (if eligible)
- Retirement & savings plan, medical/dental/vision, life/disability, flexible spending, annual bonus/incentives (as applicable), stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com.
What You Will Do
- Work on late-stage drug product formulation and process development for biologics modalities (e.g., monoclonal antibodies, BiTEs, fusion proteins).
Responsibilities
- Conduct process development for pipeline products and support commercial products through lifecycle management.
- Design, plan, complete, and document formulation and process development studies.
- Develop/characterize/implement processes and next-gen technologies; solve technical challenges.
- Use advanced statistical/data analytics to draw conclusions and inform decisions.
- Support clinical/commercial fill/finish via process capability analysis, troubleshooting, root cause analysis, and product impact assessments.
- Author/review technical protocols, reports, product impact assessments, and regulatory sections for IND/marketing submissions.
- Communicate progress to management and cross-functional partners.
- Lead cross-functional initiatives and contribute to process design improvement projects.
- Travel up to 10%.
Basic Qualifications
- Doctorate OR Master’s + 3 years OR Bachelor’s + 5 years scientific experience.
Preferred Qualifications
- Advanced degree in relevant engineering/science/pharmaceutics.
- Biopharma/biologics development & manufacturing; formulation, fill-finish, tech transfer, and statistical DoE/analysis.
- Experience with formulation/drug product characterization; scale down/up model development.
- Protein stability/process stress understanding.
- Statistical software (SAS/JMP/Minitab), critical thinking, strong project management and attention to detail; cross-functional collaboration.
Benefits (if eligible)
- Retirement & savings plan, medical/dental/vision, life/disability, flexible spending, annual bonus/incentives (as applicable), stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com.