Process Development Senior Associate

About the role

Amgen is hiring a Process Development Senior Associate in its Pivotal Drug Product Technologies group in Thousand Oaks, CA. The group supports commercial formulation development and formulation/fill/finish process development for late-stage biologics, working with engineers and scientists on the technical aspects of drug product commercialization and lifecycle management.

Key responsibilities

• Take part in planning and designing formulation and process development studies, applying basic science and engineering skills
• Run and document laboratory studies accurately (UF/DF, filtration, freeze-thaw, stability)
• Evaluate product and process performance through analytical testing (U/HPLC, particle analysis, moisture content)
• Build data and analytics solutions using tools such as TIBCO Spotfire and MS Smartsheet, and analyse data with statistical software (JMP, SAS)
• Use digital tools to automate data structuring, analyse large datasets and create visualizations
• Write and review technical protocols and reports, and share study designs, results and challenges in team meetings

Required profile

• Basic qualification: Master's degree, or Bachelor's degree with 2 years of scientific experience, or Associate's degree with 4 years, or high school diploma/GED with 6 years of scientific experience
• Preferred: degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or a related field
• Preferred: 1+ years in pharmaceuticals/biotechnology covering process characterization, formulation development, equipment design and implementation, and technology transfers
• Preferred: familiarity with drug product unit operations (ultrafiltration/diafiltration, filling, filtration, mixing) and analytical techniques (SEC, CEX, HIAC, MFI); understanding of protein stability and ADCs preferred

Required skills

• Proficiency in at least one statistical software package (SAS, JMP or Minitab)
• Programming (Python, R, MATLAB) and database languages (SQL), plus data visualization tools (Tableau, Spotfire, D3.js)
• Ability to learn quickly, multitask, keep accurate records, communicate orally and in writing, and solve problems independently

What we offer

• Annual salary range of $80,044.50 to $108,295.50, depending on skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, flexible work models where possible