Process Development Senior Scientist - Drug Product Technologies

** 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 Senior Scientist - Drug Product Technologies*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will bring hands-on experience 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.

+ 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.

+ Plan, lead, and execute formulation, stability, process development, and fill/finish studies for early-stage drug product programs across diverse biologic modalities.

+ 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 drug product development.

+ 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, where applicable, ADC- or oligonucleotide-specific attributes such as drug-to-antibody ratio, free payload, linker-payload integrity, and oligonucleotide purity or degradation pathways.

+ Leverage high-throughput and data-driven tools for formulation screening, stability assessment, develop ability evaluation, and processability characterization.

+ Identify and address technology gaps impacting drug product stability, manufacturability, excipient interactions, modality-specific degradation pathways, and process-related stress responses.

+ Apply machine learning, AI, automation, and data science approaches to predictive modeling, workflow acceleration, data integration, and decision-making.

+ Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.

+ Provide scientific and technical leadership in biologics drug product development, serving as a subject matter expert for formulation, stability, process development, and modality-specific considerations for ADCs, oligonucleotides, and other complex biologics.

+ Define and influence drug product development strategies across programs by identifying key risks, recommending phase-appropriate studies, and integrating formulation, analytical, process, manufacturability, and regulatory considerations into program decisions.

+ Serve as a recognized scientific resource within area of expertise, providing technical guidance, mentorship, and coaching to junior scientists and cross-functional team members.

+ Author and review technical documents, formulation and process development reports, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and technology transfer packages.

+ Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit…