Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

THOUSAND OAKS (US)ONSITEPOSTED: 8/10/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE DEFINITION & RESPONSIBILITIES

Design and develop liquid and lyophilized formulations for early-stage biologic candidates, including monoclonal antibodies and multispecifics.
Develop and optimize lab-scale sterile fill/finish unit operations to support scalable drug product development.
Characterize critical quality attributes (CQAs) such as aggregation, charge/size variants, subvisible particles, and protein-excipient interactions.
Implement laboratory automation, robotic liquid handling systems (e.g., Hamilton, Tecan), and automated sample preparation workflows to accelerate high-throughput screening.
Apply Design of Experiments (DoE), predictive modeling, machine learning, and advanced data science to guide formulation design and decision-making.
Author technical reports, IND/CTA regulatory submissions, risk assessments, and technology transfer documentation for internal/external CDMO execution.

REQUIRED VERIFIED SKILLS

Formulation Development
Lyophilization
Biologics Drug Product
Fill/Finish Operations
High-Throughput Screening
Laboratory Automation
Design of Experiments (DoE)
Biophysical Characterization
Regulatory Submissions
Technology Transfer

COMPENSATION & REWARDS

USD 1.3L - 1.7L per annum

ORGANIZATION CONTEXT & CULTURE

Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.

TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals

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