Career CategoryManufacturing
Job DescriptionAssociate ManufacturingWhat you will doLet'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.
Key Responsibilities- 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
Work Environment- Must be available to work onsite
- Must be able to work in a clean room environment wearing steel-toe shoes, full clean room gowning, hairnet, and gloves while following GMP documentation with strict adherence to safety and compliance
- Must be available to work various shifts, including day, swing, graves, weekends, holidays, 5x8-hour shifts, 4x10-hour shifts, and 3x12- or 4x12-hour shifts, as dictated by the production schedule
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications: - 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
Preferred Qualifications: - 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 you can expect of usAs 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.
Salary Range70,985.20USD -96,038.80 USD
