Senior Scientist, Drug Product Technologies

About this role

Career Category Operations 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.

Senior Scientist

What you will do Let’s do this. Let’s change the world. We are seeking a Senior Scientist for our Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). The Sr. Scientist will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. The candidate will need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs. The Sr Scientist will Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes to advance Amgen practices and ensure success through the commercialization process.

The Sr. Scientist will provide support for Amgen’s biologics drug product and process design, commercialization and lifecycle management. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product and process development. The Sr Scientist will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceeduralize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modeling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements. A successful candidate will be able to work independently, taking responsibility of projects and self-managing their work packages with appropriate communication and escalation. A successful candidate will thrive in a multi-functional team environment, adeptly collaborating and liaising with colleagues within the function, as well as partner organizations across Operations. Finally, a successful candidate will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development. This position requires (up to 10%) travel to domestic and international sites.

Key Responsibilities: • Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management • Apply basic science/engineering skills and first principles modeling to solve technical problems • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management. • Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software. • Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements. • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions. • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs. • Ability to travel domestically and internationally up to 10% of the time. • Conducts risk assessment for inspection operations and propose / implement appropriate CAPA. • Identifies and implements operational opportunities for current and new inspection operations. • Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. • Development of Validation Plans, IOQs and PQs • Ensure that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Recommendations to Site Validation Guidance Documents • Assist in deviation and exception resolution and root cause analysis. • Participate as required in project activities. • Coordinates and organizes resources needed to complete tasks

What we expect of you We are all different, yet we all use our unique contributions

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