Sr Engineer - Drug Product Pilot Plant

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.

Sr Engineer - Drug Product Pilot Plant

What you will do

Let’s do this! Let’s change the world!

In this role you will provide technical leadership to Amgen’s parenteral drug product process design and commercialization. The candidate will lead off-line process characterization activities and work with global technology transfer team to transfer the process to clinical/ commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required. The candidate will also play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support development of in silico models to enable rapid, robust, process development.

Responsibilities include:

• Operate and trouble shoot filling equipment for characterization, special studies, and/or material generation to support the Amgen network

• Design, implement and document technical data packages related to drug product process design, development and characterization

• Meticulous review of protocols, and study design, to streamline execution and ensure successful implementation

• Support development of models and other data analytics tools for rapid process development and tech transfer

• Drive innovations in drug product process characterization and reduce pilot plant and clinical/ commercial GMP line time required for successful technology transfers and NPIs

• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues, improve and develop new processes and evaluate effects of equipment changes, scale, and implementation of new raw materials

• Serve as an authority on manufacturing technologies (e.g. filling, automated visual inspection) and work with global multi-functional teams to develop and improve shared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants

• Apply strong written and verbal communicational skills. Author technical protocols, reports and present findings and project status

• Contribute to and maintain a strong culture of safety and compliance in the plant

• Travel domestically and internationally may be required

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience OR

• Associate’s degree and 8 years of Engineering experience OR

• Bachelor’s degree and 4 years of Engineering experience OR

• Master’s degree and 2 years of Engineering experience OR

• Doctorate degree

Preferred Qualifications:

• Advanced degree in engineering, biotechnology, life sciences or related subject area

• 2+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites

• Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations

• Knowledge of, and hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, visual inspection operations etc.)

• Ability to lead innovation, collaborate in a multi-functional team, and act on dynamic information at a rapid pace

• Ability to independently design a