Process Development Associate – Large Molecule Release Testing

Amgen Inc.; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Total rewards plan

Discretionary annual bonus

Stock-based incentives

Flexible work models

Retirement and savings plan

Job summary

Amgen Inc. is seeking a Process Development Associate for Large Molecule Release Testing in Thousand Oaks, CA. The role focuses on defining critical quality attributes and advancing analytical tools to support development within a GMP environment.

The candidate will perform cell culture, ELISA, qPCR and binding assays, generate robust data, and support method transfers and reagents inventory management. Strong teamwork and documentation skills are essential in this fast-paced setting.

Qualifications

• Bachelor0s degree required (or equivalent).
• Associate0s degree with 2+ years scientific experience acceptable.
• GxP regulatory understanding preferred.

Responsibilities

• Cell culture maintenance, reagents/media/buffer prep and support.
• Routine lab maintenance (restocking, ordering, safety/audit readiness).
• Perform cell-based, binding, ELISA and qPCR assays.
• Generate robust data and report in validated systems with minimal direction.
• Support method hand-off and troubleshooting.
• Inventory management for critical reagents with detailed counts.

Skills

Cell culture

ELISA

qPCR

Binding assays

Data analysis

Documentation

Teamwork

Communication

Education

Bachelor0s degree

Associate0s degree + 2 years

High school diploma/GED + 4 years

Job description

Process Development Associate – Large Molecule Release Testing

What you will doLet’s do this. Let’s change the world. In this vital role you will be 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.
• Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction.
• Supporting method hand-off and troubleshooting.
• Supporting critical reagents freezer inventory management through detailed manual counts and maintenance of inventory tracking records.

What we expect of you

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

Basic Qualifications:

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

Preferred Qualifications:

• 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, binding assays, immunoassays, and qPCR.
• Experience developing, qualifying, and testing analytical methods.
• Excellent teamwork skills working in a fast-paced GMP environment.
• 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship: Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.