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 join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on antibody-drug conjugates (ADCs), as well as monoclonal antibodies, multispecifics and other biologic modalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs);

establishing robust, scalable fill/finish processes for complex biologic drug products; and authoring and supporting high quality regulatory submissions.

The ideal candidate will bring hands-on experience in ADC drug product formulation and drug product process development, including a mechanistic understanding of linker-payload attributes, stability/process-relevant degradation pathways, and analytical strategies used to characterize ADC CQAs. This candidate will integrate formulation, analytical, and process data to guide product design, apply cutting-edge technologies (including AI/ML), and collaborate cross-functionally to deliver high-quality, stable, and manufacturable drug products for clinical development in a fast-paced environment.

** Key Responsibilities*
* + Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.

+ Plan and execute formulation and fill/finish process studies for early-stage programs.

+ Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling.

+ Build process understanding across unit operations to support scalable drug product development.

+ Evaluate in-use compatibility and drug product stability under clinical conditions.

+ Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.

+ Leverage high-throughput tools for formulation screening and processability assessments.

+ Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses.

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

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

+ Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.

+ Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.

+ Present findings to internal/external stakeholders and participate in cross-functional teams.

** What we expect of you*
* We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.

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* Basic Qualifications:

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* + Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

+ OR

+ Master's degree and 3 years of Scientific experience

+ OR

+ Bachelor's degree and 5 years of Scientific experience

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* Preferred Qualifications:

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* + PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2-4 years of postdoc or industry experience.

+ Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation…