Process Development Senior Associate
Amgen
June 26, 2026
On-site
Thousand Oaks, CA
Operations
Process Development Senior Associate
What You Will Do
- Join Pivotal Drug Product Technologies to develop, characterize, and support commercialization of drug product manufacturing processes for late-stage programs.
- Lead late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., mAbs, BiTEs, fusion proteins).
Responsibilities
- Plan and design formulation/process development studies using scientific/engineering knowledge.
- Execute and document lab studies accurately (UF/DF, filtration, freeze-thaw, stability).
- Evaluate product/process performance via analytical testing (U/HPLC, particle analysis, moisture content).
- Build data/analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet.
- Perform statistical analysis (e.g., JMP, SAS).
- 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/GED + 6 years scientific experience.
Preferred Qualifications/Skills
- Degree in relevant fields (Chemical Eng., Biomedical Eng., Biochemistry, Biotechnology, Pharmaceutics, etc.).
- 1+ year pharma/biotech experience (process characterization, formulation development, equipment design/implementation, tech transfers).
- Knowledge of drug product unit operations and analytics (e.g., SEC, CEX, HIAC, MFI).
- Protein stability understanding; statistical software (SAS/JMP/Minitab); programming (Python/R/MATLAB), SQL, and visualization tools (Tableau/Spotfire/D3js).
- Strong records, organization, attention to detail, communication.
Benefits (Total Rewards Plan, based on eligibility)
- Medical/dental/vision, life/disability, retirement/savings plan, flexible spending, bonus/incentives, 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
- Join Pivotal Drug Product Technologies to develop, characterize, and support commercialization of drug product manufacturing processes for late-stage programs.
- Lead late-stage drug product formulation and fill/finish process development for large molecule modalities (e.g., mAbs, BiTEs, fusion proteins).
Responsibilities
- Plan and design formulation/process development studies using scientific/engineering knowledge.
- Execute and document lab studies accurately (UF/DF, filtration, freeze-thaw, stability).
- Evaluate product/process performance via analytical testing (U/HPLC, particle analysis, moisture content).
- Build data/analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet.
- Perform statistical analysis (e.g., JMP, SAS).
- 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/GED + 6 years scientific experience.
Preferred Qualifications/Skills
- Degree in relevant fields (Chemical Eng., Biomedical Eng., Biochemistry, Biotechnology, Pharmaceutics, etc.).
- 1+ year pharma/biotech experience (process characterization, formulation development, equipment design/implementation, tech transfers).
- Knowledge of drug product unit operations and analytics (e.g., SEC, CEX, HIAC, MFI).
- Protein stability understanding; statistical software (SAS/JMP/Minitab); programming (Python/R/MATLAB), SQL, and visualization tools (Tableau/Spotfire/D3js).
- Strong records, organization, attention to detail, communication.
Benefits (Total Rewards Plan, based on eligibility)
- Medical/dental/vision, life/disability, retirement/savings plan, flexible spending, bonus/incentives, stock-based long-term incentives, time off, and flexible work models where possible.
Application Instructions
- Apply now at careers.amgen.com.