Process Development Senior Scientist - Pre-Pivotal 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 Sr Scientist*
* ** 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 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.

+ Responsibility 1 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 biologics 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 biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.

+ Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.

+ Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.

+ Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization.

+ Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.

+ Identify and address technology gaps impacting biologics stability, protein-excipient interactions, and process-related stress responses.

+ Apply machine learning, AI, laboratory automation, and advanced 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 professional we seek is a leader with these qualifications.

*
* Basic Qualifications:

*
* Doctorate degree PhD OR PharmD OR MD

OR

Master's degree and 3 years of  
** Scientific
* * experience

OR

Bachelor's degree and 5 years of  
** Scientific
* * experience

*
* Preferred Qualifications:

*
* + Requirement 1 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 biologics drug product formulation experience is strongly preferred.

+…