Process Development Principal Scientist – Drug Product Technologies

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead Biologics drug product formulation and process development in the Pre-Pivotal Drug Product Technologies group. You will design, develop, and optimize formulations for diverse modalities including ADCs and oligonucleotides, integrating analytical data to drive scalable processes for clinical development.

The ideal candidate brings hands-on leadership in biologics development, experience with CQAs, and cross-functional

Qualifications

• Experience in biologics drug product formulation and process development.
• Strong track record in analytical characterization of biologics.
• Leadership of cross-functional teams in a matrix environment.

Responsibilities

• Lead Drug Product teams in planning, designing, executing, and documenting studies for formulation and process development.
• Collaborate across process development, research, analytical, regulatory, quality, manufacturing and external partners.
• Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other biologics.
• Build process understanding across unit operations to enable scalable drug product development.
• Support regulatory submissions with high-quality documentation.

Skills

Biologics formulation

Process development

Analytical characterization

Leadership

Cross-functional collaboration

AI/ML awareness

Tools

AI/ML

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Principal Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will join the Pre-Pivotal Drug Product Technologies group, which is responsible for early‑stage drug product development across diverse modalities, including antibody‑drug conjugates (ADCs), oligonucleotides such as siRNAs, monoclonal antibodies, multispecifics, and other complex biologics. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust, scalable fill/finish processes; and authoring and supporting high‑quality regulatory submissions.

The ideal candidate will bring hands‑on experience and leadership in biologics drug product formulation, process development, and/or analytical characterization, with experience in ADCs and/or oligonucleotides such as siRNAs strongly preferred. The candidate will integrate formulation, analytical, stability, and process data to guide product design and development, including modality‑specific considerations such as linker‑payload attributes, stability‑and process‑relevant degradation pathways, ADC CQAs, oligonucleotide formulation and stability considerations, and phase‑appropriate analytical strategies. This individual will apply scientific judgment, emerging technologies including AI/ML, and strong cross‑functional collaboration to deliver high‑quality, stable, and manufacturable drug products for clinical development in a fast‑paced environment.

• Serve as a leader on Drug Product teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, process development, technology transfer, and regulatory authoring in support of advancing Amgen’s diverse biologics pipeline.
• Work effectively in a fast‑paced, matrixed environment, collaborating across process development, research, analytical, regulatory, quality, manufacturing, and external partner teams to advance programs, influence development strategies, and communicate technical recommendations to scientific peers and leadership.
• Develop and characterize liquid and lyophilized formulations for complex biologics, including ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other emerging modalities.
• Build process understanding across unit operations to support scalable drugproductdevelopment.
• Evaluate in‑use compatibility and drug product stability under clinically relevant conditions.
• Investigate biologics‑and modality‑relevant CQAs, including aggregation, fragmentation, charge and size variants, subvisible particles, surface interactions, concentration‑dependent behavior, and