Process Development Associate – Large Molecule Release Testing

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

Benefits offered by this job

Retirement and Savings Plan

Medical, dental & vision care

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Process Development Associate – Large Molecule Release Testing in Thousand Oaks, CA. In this role you will define critical quality attributes and advance analytical tools to support development.

The LMRT team collaborates with cross-functional partners to enable release and stability testing in a phase-appropriate GMP environment. Responsibilities include cell culture maintenance, assay execution (ELISA, qPCR), data generation in validated systems, method hand-off, inventory

Qualifications

• Bachelor's degree in a scientific field.
• Associate's degree with 2+ years of scientific experience.
• High school diploma with 4+ years of scientific experience.

Responsibilities

• Cell culture maintenance and preparation of reagents/media/buffer.
• Performing cell-based assays, binding assays, ELISA and qPCR assays.
• Generating robust data and reporting in a validated system.
• Supporting method hand-off and troubleshooting.
• Managing reagents freezer inventory and tracking records.

Skills

Cell culture

Bioassays

qPCR

ELISA

Immunoassays

Analytical methods

Documentation

GxP experience

Communication

Education

Bachelor's degree

Associate's degree with 2 years of scientific experience

High school diploma with 4 years of scientific experience

Tools

LIMS

qPCR instruments

ELISA readers

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. 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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.