Process Development Senior Associate

Amgen•Thousand Oaks, CA

2d•$80,045 - $108,296

About The Position

Amgen is seeking a motivated and collaborative Process Development Associate Scientist to join the Oral and Enabling Delivery Systems (O&EDS) group within Drug Product Technologies (DPT). The role contributes to development of oral solid dosage forms for early-stage clinical programs through hands-on laboratory experimentation, data analysis, and cross-functional collaboration with Drug Product and Drug Substance development partners. It is suited to someone with foundational laboratory experience who is progressing toward greater scientific ownership, including contributing to experimental design and improving team workflows and tools. The position involves developing formulations and processes, characterizing materials and powders, interpreting experimental results, and applying scientific judgment to assess process performance and product quality. The associate documents work in electronic laboratory notebooks in accordance with GMP and internal standards, communicates results and recommendations, supports team systems and workflow improvements, and contributes to scale-up and technology transfer as needed.

Requirements

A master's degree; or a bachelor's degree and 2 years of formulation laboratory experience; or an associate's degree and 6 years of formulation laboratory experience; or a high school diploma/GED and 8 years of formulation laboratory experience.
Hands-on laboratory experience in formulation development, including oral solid dosage form experiments and key unit operations such as blending, dry granulation, and compression.
Ability to analyze and interpret experimental data and apply scientific judgment to development decisions.
Ability to document work in electronic laboratory notebooks and comply with GMP requirements and internal standards.
Ability to collaborate cross-functionally and communicate results through written reports and technical presentations.

Nice To Haves

A 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.
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.
Ability to manage multiple priorities while maintaining attention to detail.
Strong written and verbal communication skills.

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, and 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, identify risks, and propose next steps using scientific judgment.
Contribute to the development, maintenance, and continuous improvement of team tools and systems, including SharePoint-based platforms, knowledge repositories, and workflow tracking tools.
Support scale-up activities and technology transfer as needed.