Process Development - Senior Scientist

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.

Process Development - Senior Scientist

What you will do

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

Amgen is currently seeking a Process Development Senior Scientist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the critical quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pre-Pivotal AS organization’s focus is on supporting analytical method development and product characterization to advance candidates from research to first-in-human (FIH) clinical trials.

The Process Development Senior Scientist will contribute to Amgen’s diverse early-stage portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the product quality attributes of biotherapeutics being developed across multiple therapeutic areas in Amgen’s pipeline. The candidate will be responsible for analytical leadership of pre-pivotal programs and the implementation of sophisticated analytical techniques to characterize novel modalities in the pipeline.

Key Responsibilities

• Serve as Attribute Sciences Team/Technical Lead (ASTL) to support lead molecule selection and development through FIH clinical trials

• Independently design and execute experiments to gain fundamental understanding of product quality attributes and stability characteristics of biotherapeutics

• Develop and optimize analytical methods (e.g. HPLC/UHPLC, CE) to ensure method performance, reliability, efficiency, and sustainability

• Support drug substance and drug product process development by providing technical and strategic input

• Develop and deploy in silico analysis and data science platforms to enhance attribute understanding, consolidate data, and enable generation of cross product insights

• Effectively communicate with key stakeholders from peers to senior management across functions through presentations and written communications

• Coordinate technology transfer with internal and external partners to ensure proper control strategies and regulatory compliance

• Author regulatory documents and understand expectations for analytical methods, control and stability strategy, and comparability

• Actively collaborate with cross-functional partners in Research, Process Development, Product Quality, and Manufacturing to drive innovation and continuous improvement

• Engage with industry, academia, and regulatory authorities through publications, conferences, and participation in consortia to stay current with and shape emerging analytical technology, attribute understanding, and data science approaches

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 5 years of Scientific experience OR

• Master’s degree and 3 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]

Preferred Qualifications:

• Ph.D. in biochemistry, biophysics, bioengineering, chemistry, or other life science areas plus 2 or more years of industry experience

• Strong lab skills to design and execute scientific experiments with high safety standards and ability to be resourceful and creative

• Strong foundation in data analysis and interpretation, with the