Process Development Associate Large Molecule Release Testing

Amgen • Thousand Oaks, CA

3d

About The Position

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 - Large Molecule Release Testing 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 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 for the PD Associate role include: Cell culture maintenance, reagents/media/buffer preparation, and relevant support. Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness. Performing cell-based assays, binding assays, ELISA and qPCR assays etc. Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction. Supporting method hand-off and troubleshooting. Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo. Managing critical reagent extensions by reviewing monthly needs, submitting requests with supporting assay data, and updating COA. 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The lab-based professional we seek is a scientist with the following qualifications.

Requirements

• High school diploma / GED and 4 years of Scientific experience OR Associate's degree and 2 years of Scientific experience OR Bachelor's degree

Nice To Haves

• B.S. or M.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 cell culture, cell-based bioassay, immunoassays, and qPCR etc.
• 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.

Responsibilities

• Cell culture maintenance, reagents/media/buffer preparation, and relevant support.
• Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness.
• Performing cell-based assays, binding assays, ELISA and qPCR assays etc.
• Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction.
• Supporting method hand-off and troubleshooting.
• Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo.
• Managing critical reagent extensions by reviewing monthly needs, submitting requests with supporting assay data, and updating COA.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees