Process Development Associate Large Molecule Release Testing, Pre-Pivotal Attribute Science

About the Role

The Attribute Sciences (AS) department within the Process Development (PD) organization is responsible for defining the critical quality attributes of Amgen's therapies and advancing innovative analytical tools to support their development. Within AS, the Large Molecule Release Testing (LMRT) team in the Pre-Pivotal Biologics Attribute Sciences function supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment. The LMRT team collaborates closely with cross-functional partners to support analytical method co-development, co-qualification, and method transfer activities.

Key Responsibilities

• Good understanding of cGMP principles and follow compliance requirements in routine day to day work.
• Technical support of incoming method transfer/qualification, method optimization, troubleshooting method related issues, and investigations in an early phase GMP environment.
• Implementing and executing compendial methods (Protein conc, pH, Osmolarity, color, clarity etc), chromatography and capillary electrophoresis methods 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
• Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness.
• Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo.
• Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records.
• Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results.

Basic Qualifications

• Bachelors degree OR
• Associates degree and 2 years of experience OR
• High school diploma / GED and 4 years of experience

Preferred Qualifications

• B.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area
• Demonstrated ability in the biotech industry, including but not limited to GxP regulations.
• Experience in compendial techniques, chromatography and capillary electrophoresis techniques.
• Experience developing, qualifying, and testing analytical methods.
• Excellent Documentation Skills, Including An Understanding Of GxP Requirements.
• Excellent communication (oral and written) skills and attention to detail.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of:

• 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
• A 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
• Flexible work models where possible