Process Development Associate – Large Molecule Release Testing

Amgen; Thousand Oaks (CA); On-site; USD 75,000 - 101,000; Full time

Job summary

Amgen seeks a Process Development Associate – Large Molecule Release Testing in Thousand Oaks, CA, to define critical quality attributes and advance analytical tools supporting biologics development. You will work in a GMP setting within LMRT, collaborating with cross-functional partners on method co-development and transfer.

The role requires a scientific background with experience in cell culture, bioassays, and analytical methods, plus strong documentation and teamwork to ensure quality and

Qualifications

• Bachelor’s or higher in a related scientific field with relevant biotech experience.
• Experience with GxP regulations and biotech industry standards.
• Ability to develop, qualify, and test analytical methods.
• Strong teamwork and precise documentation in GMP environments.
• Excellent communication skills, both written and oral.

Responsibilities

• Define quality attributes for Amgen therapies and support analytical method development.
• Collaborate on co-development, co-qualification, and method transfer activities.
• Maintain cell culture, prep reagents/media/buffer, and support lab operations.
• Perform cell-based assays, ELISA, qPCR, and data generation with validation.
• Assist in data organization, reporting, and troubleshooting of methods.
• Manage reagents inventory and ensure audit readiness.

Skills

Cell culture

Cell-based bioassay

Binding assays

Immunoassays

qPCR

Documentation

Education

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Career Category Scientific 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 OR Associate’s degree and 2 years of Scientific experience OR 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.

Salary Range 74,503.35USD -100,798.65 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen