Manufacturing Associate

Amgen; Thousand Oaks (CA); On-site; USD 71,000 - 96,000; Full time

Job summary

Amgen in Thousand Oaks seeks an Associate Manufacturing professional to operate in a dynamic production environment, supporting development, clinical, and commercial activities. Under supervision, you’ll perform manufacturing tasks per SOPs, set up, clean, and monitor processes, and assist in documentation reviews.

The role requires a Bachelor’s or Associate’s degree with manufacturing experience or a high school diploma with industry experience, and a willingness to work 12-hour shifts.

Qualifications

• Bachelor’s degree or equivalent with manufacturing/operations experience.
• Willingness to work non-standard shifts including graveyard and weekends.
• Knowledge of GMP and basic analytical methods preferred.

Responsibilities

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers.
• Perform and monitor critical processes and complete routine validation protocols.
• Follow GMPs and draft/revise routine documents; report and escalate Quality issues.

Skills

GMP knowledge

Shift work

Problem solving

Education

Bachelor’s degree

Associate’s degree

High school diploma

Tools

LIMS

DeltaV/automation

Job description

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. 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.

Associate Manufacturing

Let’s do this. Let’s change the world. In this dynamic role you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

• Hands‑on operations, set‑up, clean, sanitize and prepare media and buffers per procedures
• Perform and monitor critical processes
• Complete routine validation protocols
• Follow GMP's
• Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
• Initiate Quality incidents
• Identify and recommend improvements related to routine functions and implement after approval
• Basic troubleshooting
• Recognize&accurately report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
• May train staff to perform hands‑on tasks
• May act as safety representative
• May participate on cross‑functional teams and represent the Purification group
• Must be flexible to work any shift assignment in support of 24/7 manufacturing operations. 12 hour shift (Days or Nights) rotation.

What we expect of you

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

Basic Qualifications

Bachelor’s degree OR Associate’s degree and 6 months of manufacturing or operations experience OR High school diploma / GED and 2 years of manufacturing or operations experience

Preferred Qualifications

• Available for non‑standard shifts including graveyard shift and weekends
• Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing CFR and Regulatory knowledge
• Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• 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 Purification equipment
• Experience with Delta V / automation

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.

Equal Opportunity employer

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.

Salary Range

Salary Range 70,985.20USD -96,038.80 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