Process Development Associate

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Associate

Live

What you will do

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

Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the critical quality characteristics of the therapies it produces and optimizes pioneering analytical tools to guide that development. The Pre-pivotal PD organization focuses on developing a wide range of early-phase therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), and antibody conjugates.

Located at our Thousand Oaks, CA site, the PD Associate will support our Biologic FIH Biologics and Rapid Analytics team as an expert in HPLC and Capillary Electrophoresis (CE) analyses, testing, and troubleshooting.

• Supporting the development and optimization of analytical methods utilizing HPLC/UPLC, CE, and compendial testing technologies to support lead candidate selections and improve method performance for different modalities at Dev MA and FIH stages with high efficiency and throughput under supervision.

• Conducting analyses utilizing size-exclusion, cation and anion exchange, affinity, and reversed-phase HPLC/UHPLC and CE techniques.

• Performing hands-on testing for molecule characterization activities and investigating method performance and reliability under minimum supervision.

• Generating, analyzing, and critically evaluating analytical data to support product development characterization, investigations, and regulatory submissions.

• Qualifying methods to enable the transfer of methods to the Rapid Analytics team and early phase GMP lab, and documenting method establishment in method transfer reports.

Win

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 self-starter with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Scientific experience OR

• Associate’s degree and 2 years of Scientific experience OR

• Bachelor’s degree

Preferred Qualifications:

• Knowledge of analytical method development, validation, and troubleshooting skills for using HPLC/UPLC, CE, and mass spectrometry.

• Strong desire to learn and a keen interest in science.

• Good written and oral communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.

• Understanding of phase-appropriate GMP compliance and documentation.

• Well-organized, with the ability to multitask, effectively plan and follow through on complex projects, and work both independently and in teams.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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