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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).
Job Responsibility:
Perform operations in the Manufacturing area, specifically B23 Purification processes
Perform hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedure
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
Requirements:
High school/GED + 2 years of manufacturing or operations work experience
Associate’s + 6 months of manufacturing or operations work experience
Bachelor’s
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
Nice to have:
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
What we offer:
Total Rewards Plan
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
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