Process Development Senior Associate

Amgen•Thousand Oaks, CA

About The Position

Amgen is seeking a motivated and collaborative Process Development Associate Scientist to join the Oral and Enabling Delivery Systems group within Drug Product Technologies. The role contributes to development of oral solid dosage forms for early-stage clinical programs through laboratory experimentation, data analysis, and cross-functional collaboration with Drug Product and Drug Substance development teams. It is suited to someone with foundational laboratory experience who is building scientific ownership, including contributions to experimental design and improvements to team workflows and tools.

Requirements

Master’s degree, or bachelor’s degree and 2 years of formulation laboratory experience, or associate’s degree and 6 years of formulation laboratory experience, or high school diploma/GED and 8 years of formulation laboratory experience.
Ability to execute formulation and process development experiments for oral solid dosage forms, including hands-on use of blending, dry granulation, and compression operations.
Ability to plan and execute routine material and powder characterization studies, analyze and interpret data, document work in electronic laboratory notebooks, and collaborate across functions.
Strong written and verbal communication skills.
Ability to manage multiple priorities while maintaining attention to detail.

Nice To Haves

Degree in Pharmaceutical Sciences, Material Sciences, Bioengineering, Chemistry, Chemical Engineering, or another relevant field, with 2 or more years of pharmaceutical industry experience emphasizing oral solid dosage forms.
Hands-on oral solid dosage form development experience, including formulation experiments and direct experience with blending, dry granulation, and compression.
Experience with powder and solid dosage form characterization techniques.
Demonstrated ability to execute experiments independently and translate results into actionable insights.
Experience contributing to experimental design and process optimization.
Experience supporting or developing team tools or systems, such as SharePoint platforms, data tracking tools, or knowledge management systems.
Working knowledge of pharmaceutical development in a GMP environment.

Responsibilities

Execute formulation and process development experiments for oral solid dosage forms, including blending, dry granulation, and compression, and assess their impact on product quality and performance.
Independently plan and execute routine material and powder characterization studies and contribute to experimental design based on results and scientific understanding.
Analyze and interpret experimental data to support formulation and process development decisions.
Document experimental work, data, and conclusions in electronic laboratory notebooks in compliance with GMP and internal standards; maintain current knowledge of cGMP requirements and SOPs.
Collaborate with cross-functional teams to support development programs and ensure alignment across functions.
Communicate results and recommendations through technical presentations and written reports to the team and management.
Evaluate process performance and product quality using scientific judgment, identify risks, and propose next steps.
Contribute to the development, maintenance, and continuous improvement of team tools and systems, such as SharePoint platforms, knowledge repositories, and workflow tracking tools.
Support scale-up activities and technology transfer as needed.