Process Development Senior Scientist - Drug Product Technologies

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets 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,multispecificsandotherbiologicmodalities. 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 anddrug product process development, includinga mechanisticunderstanding of linker-payload attributes,stability/process-relevant degradation pathways, and analytical strategies used to characterize ADCCQAs. 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.

• 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 liquidandlyophilizedformulations 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 processdesigndecisions.
• Leverage high-throughput tools for formulation screening and processability assessments.
• Identify and address technology gapsimpactingADC 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 arephase-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.

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.

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
• OR
• Masters degree and 3 years of Scientific experience
• OR
• Bachelors degree and 5 years of Scientific experience

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 24 years of postdoc or industry experience.
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred.
• Demonstrated understanding of ADC drug product development considerations, including…