Process Development Senior Associate
Amgen
August 25, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Senior Associate
What You Will Do
- Responsible for late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., monoclonal antibodies, BiTEs, fusion proteins)
- Plan and design formulation and process development studies
- Execute and document laboratory studies accurately (e.g., UF/DF, filtration, freeze-thaw, stability)
- Evaluate product/process performance via analytical testing (e.g., U/HPLC, particle analysis, moisture content)
- Build data/analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet
- Perform statistical data analysis using JMP, SAS, etc.
- Use digital tools to automate data structuring, analyze large datasets, and create visualizations
- Author/review technical protocols and reports
- Share study designs, results, and technical challenges in team meetings
Basic Qualifications
- Master’s degree
OR
- Bachelor’s degree + 2 years scientific experience
OR
- Associate’s degree + 4 years scientific experience
OR
- High school diploma/GED + 6 years scientific experience
Preferred Qualifications / Skills
- Degree in Chemical/Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related field
- 1+ years pharma/biotech experience (process characterization, formulation development, equipment design/implementation, technology transfers)
- Knowledge of drug product unit operations (e.g., UF/DF, filling, filtration, mixing) and analytical techniques (SEC, CEX, HIAC, MFI)
- Understanding protein stability and process-related stress impacts
- Proficiency in SAS/JMP/Minitab
- Programming (Python/R/MATLAB) and SQL; visualization tools (Tableau, Spotfire, D3js)
- Ability to learn new techniques, multitask, maintain accurate records, and follow instructions/policies
- Self-motivation, adaptability, critical thinking/problem solving, independent research, strong organization/attention to detail, excellent oral/written communication
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.
What You Will Do
- Responsible for late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., monoclonal antibodies, BiTEs, fusion proteins)
- Plan and design formulation and process development studies
- Execute and document laboratory studies accurately (e.g., UF/DF, filtration, freeze-thaw, stability)
- Evaluate product/process performance via analytical testing (e.g., U/HPLC, particle analysis, moisture content)
- Build data/analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet
- Perform statistical data analysis using JMP, SAS, etc.
- Use digital tools to automate data structuring, analyze large datasets, and create visualizations
- Author/review technical protocols and reports
- Share study designs, results, and technical challenges in team meetings
Basic Qualifications
- Master’s degree
OR
- Bachelor’s degree + 2 years scientific experience
OR
- Associate’s degree + 4 years scientific experience
OR
- High school diploma/GED + 6 years scientific experience
Preferred Qualifications / Skills
- Degree in Chemical/Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related field
- 1+ years pharma/biotech experience (process characterization, formulation development, equipment design/implementation, technology transfers)
- Knowledge of drug product unit operations (e.g., UF/DF, filling, filtration, mixing) and analytical techniques (SEC, CEX, HIAC, MFI)
- Understanding protein stability and process-related stress impacts
- Proficiency in SAS/JMP/Minitab
- Programming (Python/R/MATLAB) and SQL; visualization tools (Tableau, Spotfire, D3js)
- Ability to learn new techniques, multitask, maintain accurate records, and follow instructions/policies
- Self-motivation, adaptability, critical thinking/problem solving, independent research, strong organization/attention to detail, excellent oral/written communication
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications are accepted until a sufficient number are received or a candidate is selected.