Associate Manufacturing

Role Summary

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.

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

Qualifications

• Required: 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
• Preferred: 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

Skills

• Process monitoring and validation
• Documentation and technical writing
• Problem identification and troubleshooting
• Cross-functional team collaboration
• Project management and presentation

Education

• Bachelor’s degree in science or engineering (preferred)

Additional Requirements

• May involve periods of rigorous, repetitive work
• May require working around high-pressure systems and heavy equipment