Process Development Associate

About the Role

Amgen's mission is to serve patients living with serious illnesses. The Process Development Associate will contribute to this mission by pioneering the world of biotech in the fight against tough diseases.

Key Responsibilities

• Research and provide hands-on formulation and process expertise for clinical and commercial products focused on solid oral dosage forms.
• Design and develop specialized digital tools and applications for the synthetic drug products team to streamline experimental workflows and enable accurate, efficient calculation of critical parameters for data-driven decision making.
• Collaborate across departments (analytical, R&D, manufacturing) to align project goals, resolve technical challenges, and ensure timely progress, acting as a liaison to integrate diverse expertise.
• Contribute to the drafting of scientific review papers and technical guideline documents through in-depth data analysis and experimental work.
• Support scientific content development via literature research, experimental validation, and cross-functional collaboration for scientific accuracy and practical relevance.
• Interface within Drug Product Technologies and external functions as a team member to support programs and initiatives.
• Contribute to experimentation design and execution, assisting in data analysis and interpretation.
• Organize and communicate information within the team to drive optimal formulation and processes for drug development.

Requirements & Tech Stack

• Solid oral dosage forms (small molecule focus)
• Digital tools and applications
• Python, R, and MATLAB
• AI-driven digital tools and user interfaces
• GMP-compliant manufacturing operations under established SOPs
• Figma, Power BI
• IMARIS, GraphPad Prism, and Excel
• Market research, data analysis, statistical design, and literature review
• ELN systems
• Understanding of organic and physical chemistry, material sciences, and statistics.
• Understanding of unit operations and formulation principles involved in the development and manufacture of oral solid dosage forms.

Qualifications

• Master's degree (or foreign equivalent) in Bioengineering, Pharmaceutical Sciences, Chemical or Pharmaceutical Engineering, Chemistry, Life Sciences, or a related field.
• Completion of a university-level course, research project, internship, thesis, or one year of experience.
• Experience with GMP-compliant manufacturing operations.
• Experience introducing and integrating new digital modalities and visualization tools.
• Experience with image and statistical analysis tools.
• Experience in market research, data analysis, statistical design and literature review.
• Experience with ELN systems.