Associate Manufacturing

2 months ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Associate ManufacturingLive

What you will do

Lets do this Lets 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, SOPs, 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.Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.Basic Qualifications:

  • High school/GED + 2 years of manufacturing or operations work experience OR
Associates + 6 months of manufacturing or operations work experience ORBachelorsPreferred Qualifications:Bachelor's degree in Science or EngineeringKnowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.Knowledge of Single-use-SystemsCFR and Regulatory knowledgeMechanical ability/expertiseBasic statistical mathematical skillsAbility to interpret and apply GMP knowledgeUnderstanding of analytical methods for manufacturing areaDemonstrated technical writing capabilityAble to demonstrate project management skills and presentation skillsAbility to understand, apply and evaluate basic chemistry, biology and physical principlesBasic troubleshooting skills on production equipmentExperience with Delta VExperience with lab equipment/testingThrive

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.

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.

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineExternal/Internal postings:

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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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