Associate Manufacturing

Career Category

Manufacturing

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. 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.

Associate Manufacturing

What you will do

Let’s do this. Let’s change the world. In this vital role The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). This Associate is responsible for hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures and perform analytical testing. Responsibilities include:

Responsibilities:

• Perform and monitor critical processes
• Execute routine validation protocols
• Comply with GMP's
• Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
• Initiate and own quality records, such as CAPA, and CAPA-EV.
• Identify and recommend improvements related to routine functions and implement after approval
• Basic troubleshooting
• Recognize and accurately report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions (e.g. routine area audits, batch records)
• Performing activities that include periods of rigorous, repetitive work
• Working around high-pressure systems and occasionally work around heavy equipment
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
• May train staff to perform hands-on tasks
• May act as safety representative
• May participate on cross-functional teams and represent manufacturing
• Available to work on site
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.

What we expect of you

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

Basic Qualifications:

• High school/GED + 2 years of manufacturing or operations experience OR
• Associate’s + 6 months manufacturing or operations experience OR
• Bachelor’s

Preferred Qualifications:

• Bachelor's degree in Science or Engineering
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Knowledge of Single-use-Systems
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Demonstrated technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on production equipment
• Experience with Delta V
• Experience with lab equipment/testing

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)