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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, this role performs manufacturing operations within Building 23 in accordance with Standard Operating Procedures (SOPs). This position is responsible for hands-on manufacturing operations, including setup, cleaning, sanitization, media and buffer preparation, and analytical testing.
Job Responsibility
Perform and monitor critical manufacturing processes
Execute routine validation protocols
Comply with GMP requirements and all safety and compliance expectations
Draft and revise routine documents such as MPs, SOPs, and technical reports
Initiate and own quality records, including CAPA and CAPA-EV
Identify and recommend improvements to routine functions and implement approved changes
Perform basic troubleshooting and accurately recognize and report problems
Direct operators on critical processes
Assist in the review of documentation for assigned functions, including routine area audits and batch records
Perform activities that may include rigorous and repetitive work
Work around high-pressure systems and occasionally around heavy equipment
Train staff on hands-on tasks, as needed
Serve as a safety representative, as needed
Participate on cross-functional teams and represent Manufacturing, as needed
Apply technical, scientific, operational, and compliance knowledge to support implementation of new technologies into the plant
Demonstrate strategic problem-solving skills and champion continuous improvement
Requirements
High school diploma / GED and 2 years of manufacturing or operations work experience
or Associate degree and 6 months of manufacturing or operations work experience
or Bachelor’s degree
Nice to have
Bachelor’s degree in science or engineering
Knowledge of large-scale biotechnology operations such as purification, cell culture, and aseptic processing
Knowledge of single-use systems
CFR and regulatory knowledge
Mechanical aptitude
Basic statistical and mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods used in a manufacturing environment
Demonstrated technical writing capability
Project management and presentation skills
Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
Basic troubleshooting skills for production equipment
Experience with Delta V
Experience with lab equipment and testing
What we offer
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
Discretionary annual bonus program or sales-based incentive plan