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Specialist Manufacturing

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Amgen

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Location:
United States , Thousand Oaks

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

107545.40 - 145502.60 USD / Year
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Job Description:

In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgen’s pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production.

Job Responsibility:

  • Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream and drug product processes as Single Use Systems SME
  • Lead cross-function and complex projects using project management skills
  • Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process
  • Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
  • Own Quality Records, such as CCMS, CAPA, and CAPA-EV
  • 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
  • Present to inspectors on areas of expertise
  • Mentor and train junior staff
  • Ability to be on-site (flexible worker)
  • Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
  • 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
  • Support New Product introduction and projects through SUS mapping
  • Support manufacturing and quality through being an SME on the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
  • Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation
  • Lead single-use design for improvements and new materials
  • Understand single-use material capabilities and user requirements for new technologies

Requirements:

  • Doctorate degree
  • Master’s degree and 2 years of manufacturing and operations experience
  • Bachelor’s degree and 4 years of manufacturing and operations experience
  • Associate’s degree and 8 years of manufacturing and operations experience
  • High school diploma / GED and 10 years of manufacturing and operations experience
  • Degree in Engineering or Life Sciences
  • 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
  • Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
  • Ability to navigate through ambiguity and identify and deliver on key milestones
  • Ability to advise and influence using experience and data
  • Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical area
  • Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
  • Ability to drive results through leadership of cross-functional teams
  • Experience leading and managing projects
  • Understanding of single-use technologies
  • Data analysis and/or data visualization skills
  • Excellent writing skills. Presentation experience – presentation to leadership or auditors
  • Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
  • Proficiency in Smartsheet and Excel, Trackwise, Visio, pi, SAP, Spotfire

Nice to have:

  • Degree in Engineering or Life Sciences
  • 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
  • Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
  • Ability to navigate through ambiguity and identify and deliver on key milestones
  • Ability to advise and influence using experience and data
  • Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical area
  • Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
  • Ability to drive results through leadership of cross-functional teams
  • Experience leading and managing projects
  • Understanding of single-use technologies
  • Data analysis and/or data visualization skills
  • Excellent writing skills. Presentation experience – presentation to leadership or auditors
  • Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
  • Proficiency in Smartsheet and Excel, Trackwise, Visio, pi, SAP, Spotfire
What we offer:
  • 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

Additional Information:

Job Posted:
April 20, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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