Biologics Formulation Scientist – Pre-Pivotal DP Tech

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a Process Development Associate Scientist to join the Pre-Pivotal Drug Product Technologies group, focusing on early-stage biologics formulation and fill/finish processes. You will design, develop, and scale liquid and lyophilized formulations, evaluate CQAs, and author regulatory support documentation.

The role emphasizes automation, high-throughput methods, and data-driven decision making within a matrixed team, contributing to IND submissions and robust process development.

Qualifications

• Masters degree in a relevant field; or Bachelor's with 2+ years of scientific experience; or Associate's with 4+ years of scientific experience; or high school with 6+ years of scientific experience.
• Hands-on experience with high-throughput formulation development and automated liquid handling systems.
• Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity.

Responsibilities

• Plan and execute formulation, stability, end-use compatibility, and fill/finish process studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, with emphasis on drug product formulation, handling, and lab-scale sterile filling.
• Investigate CQAs to inform formulation and process decisions.
• Design and execute automated high-throughput formulation screening workflows.
• Develop and implement laboratory automation solutions to improve throughput and data quality.
• Apply DoE and HT experimentation with automation for formulation and process development.
• Collaborate cross-functionally to address technology gaps affecting biologics stability and processing.

Education

Master's degree

Bachelor's degree and 2 years of Scientific experience

Associates degree and 4 years of Scientific experience

High school diploma / GED and 6 years of Scientific experience

Tools

Hamilton automation systems

Tecan automation

Beckman Coulter

Opentrons

Job description

Amgen is seeking a Process Development Associate Scientist to join the Pre-Pivotal Drug Product Technologies group, focusing on early-stage biologics formulation and fill/finish processes. You will design, develop, and scale liquid and lyophilized formulations, evaluate CQAs, and author regulatory support documentation.

The role emphasizes automation, high-throughput methods, and data-driven decision making within a matrixed team, contributing to IND submissions and robust process development.