Associate Manufacturing
3 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Associate Manufacturing
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, employee 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 procedures and perform analytical testing. Responsibilities include:
Perform and monitor critical processes
Execute routine validation protocols
Comply with GMP's
Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports)
Initiate and own quality records, such as CAPA, and CAPA-EV.
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. 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 (day, swing, 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 on cross-functional teams and represent manufacturing
Available to work on site
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
Demonstrate strategic problem-solving skills and champion continual improvement.
Basic Qualifications:
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 Qualifications:
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
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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