Associate Manufacturing

Amgen•Thousand Oaks, CA

24d

About The Position

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! 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, employees 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 procedure.

Requirements

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

Nice To Haves

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

Responsibilities

Perform and monitor critical processes
Complete routine validation protocols
Align with 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 and 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)
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 (days, swings, 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 and represent group on cross-functional teams

Benefits

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.

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