Sr Engineer-Filling, Pivotal Drug Product Technologies

Career Category

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. 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 Engineer-Filling, Pivotal Drug Product Technologies

What you will do

Let’s do this. Let’s change the world. As part of the Drug Product Technologies group, we are seeking a Senior Engineer for our Pivotal 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). Additionally, the position requires expertise in the field of aseptic processing and filling. The Sr. Engineer will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process. The Sr. Engineer 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. Engineer will provide support for Amgen’s biologics drug product and process design, commercialization and lifecycle management. The Sr. Engineer 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 Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceduralize 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

Responsibilities include:

• Partner with cross functional SMEs in the DP manufacturing network to complete Filling characterization, recipe development to enabling tech transfers and NPIs into the clinical and manufacturing network.

• 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

• Collaborate across departments to drive process improvements, find opportunities, provide support and facilitate cross-site knowledge sharing.

• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.

• 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.

• Engage in the use and development of in-silico modeling tools.

• 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.

• Provide periodic support in the authorship of manuscripts, technical articles, departmental wo