Process Development Associate Scientist – Attribute Sciences

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 Associate Scientist – Attribute Science

What you will do

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

Attribute Sciences group within Process Development provides scientific and technical expertise to support development and commercialization of Amgen’s pipeline of drug candidates. The department identifies and coordinates the achievement of desired product quality attributes towards target product profiles, develops and applies fit-for-purpose analytical methodologies.

Amgen's Pre-Pivotal Attribute Sciences group in Thousand Oaks, California is seeking an Associate Scientist. The successful candidate will be responsible for providing technical assessments using HPLC and Capillary Electrophoresis (CE) techniques for early phase GMP biologic materials and supporting troubleshooting method related issues, transferring method into an early phase GMP laboratory, and delivering attribute characterization data in a compliance manner. The candidate should have proven skills and extensive experiences in LC, CE, or related analytical methods used to test diverse modalities including monoclonal, bispecific antibodies, bispecific T-cell engagers (“BiTEs”), and other protein modalities. This individual will be a part of a team at the interface with early phase attribute sciences development teams.

Pre-Pivotal Attribute Sciences Scientist Key Responsibilities:

• Good understanding of cGMP principles and follow compliance requirements in routine day to day work.

• Technical leadership in support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment.

• Implementing and executing LC/CE as part of the product release testing, stability testing, characterization, method optimization, investigations, and regulatory submissions.

• Documenting all experiments following Good Documentation Practices. Generating, analyzing, and critical evaluation of analytical data to support product release and stability, process characterization, investigations, and regulatory submissions

• May participate or contribute to critical activities to support analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation

• Provides training and mentoring to junior staff

• Duties may include managing timelines and resources to delivery to major milestones, participating in process improvement and strategy development .

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 a individual with these qualifications.

Basic Qualifications:

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

• Master’s degree and 1 year of Scientific experience

Preferred Qualifications:

• Hands-on experience in developing and implementing methods for clinical products, in-process samples, and process characterization.

• Good understanding of Liquid Chromatography, Capillary Electrophoresis, and strong technical skills in understanding proteins and peptides

• Strong trouble shooting and critical thinking skills.

• Excellent written and oral communication skills for presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment

• Attention to details and following good documentation practices.

• Experience and ability to perform method qualification/validation