ADC Drug Product Development Lead Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 190,000 - 250,000; Full time

Job summary

Amgen is seeking a Process Development Senior Principal Scientist in Thousand Oaks, CA to lead drug product formulation and process development for biologics and ADC programs. You will provide technical leadership, integrate data across formulation, analytical, and process domains, and drive successful tech transfers.

The role emphasizes mechanistic formulation understanding, stability pathways, regulatory readiness, and collaboration across global teams in a fast-paced environment.

Qualifications

• <b>Basic Qualifications</b> include doctorate or equivalent with 2+ years scientific experience or master’s with 5+ years or bachelor’s with 7+ years.
• <b>Preferred Qualifications</b> cover advanced degree in Engineering/Biotech, 8+ years pharma/biotech, formulation and fill/finish experience, regulatory authoring, and ADC drug product knowledge.

Responsibilities

• Lead planning, design, and execution of lab studies for drug product design and process development.
• Deliver progress reports and management updates on program status and needs.
• Author and review regulatory and technical documents and submissions.
• Develop and characterize liquid and lyophilized formulations for biologics and ADC products.
• Lead tech transfer activities with CMOs/CDMOs and troubleshoot campaigns.
• Apply ML/AI for predictive modeling and decision support.
• Manage a matrix team to align commercialization and lifecycle objectives.
• Travel up to 10% domestically/internationally.

Skills

ADC drug product formulation

Drug product process development

AI/ML in pharmaceutical R&D

Data science and predictive modeling

Cross-functional leadership

Education

PhD/PharmD/MD with 2+ years science experience

MS with 5+ years science experience

BS with 7+ years science experience

Tools

Python

R

MATLAB

SQL

Tableau/Spotfire/D3.js

SAS/JMP/Minitab

UPLC/HPLC

SEC/IEX

Job description

Amgen is seeking a Process Development Senior Principal Scientist in Thousand Oaks, CA to lead drug product formulation and process development for biologics and ADC programs. You will provide technical leadership, integrate data across formulation, analytical, and process domains, and drive successful tech transfers.

The role emphasizes mechanistic formulation understanding, stability pathways, regulatory readiness, and collaboration across global teams in a fast-paced environment.