Manufacturing Senior Associate – Single Use Systems (SUS)

Amgen; Holly Springs (NC); On-site; USD 86,000 - 116,000; Full time

Benefits offered by this job

Flexible work models

Annual bonus

Stock-based incentives

Retirement plan

Comprehensive benefits

Job summary

Amgen is seeking a Manufacturing Senior Associate focused on Single-Use Systems (SUS) to join our FleX Batch facility in North Carolina. You will support SUS mapping, editing SOPs, and troubleshoot on the floor, coordinating investigations and ENGAGE with suppliers on EN/SICAR records.

You’ll collaborate with CI teams and end users to drive improvements in tubing, kitting, and flow, while preparing trackers and supporting cross-functional projects.

Qualifications

• Experience with Single-Use Systems (SUS) in drug substance manufacturing.
• Experience in GMP manufacturing support roles or process development.
• Ability to communicate complex technical information clearly.
• Experience with cross-functional collaboration and leadership.
• Experience with manufacturing systems and 24x7 operations.

Responsibilities

• Support New Product introduction and SUS mapping/drawing.
• Maintain and edit SUS SOPs and documents.
• Troubleshoot SUS on the floor and lead investigations.
• Initiate EN/SICAR records and coordinate with vendors.
• Manage trackers for EN/SICAR/EE and lead small projects.
• Collaborate with CI leads to drive SUS improvements.
• Engage with end users to understand material capabilities.

Skills

SUS mapping

SOP editing

Troubleshooting

Event notification

SICAR records

Cross-functional leadership

Data analysis

Written communication

Presentation skills

CI collaboration

Education

High School diploma or GED

Associate’s degree in Engineering or Operations

Bachelor’s degree in Engineering or Operations

Master’s degree

Tools

Smartsheet

Excel

Trackwise

Veeva

Visio

Lucidchart

Job description

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Manufacturing Senior Associate – Single Use Systems (SUS) Live

What you will do

Let’s do this. Let’s change the world.

• Support New Product introduction and projects through SUS mapping/drawing.
• Maintain and edit SUS Standard Operating Procedures (SOP).
• Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
• Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
• Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
• Provide input for ANC representative to SUS network for improvements and troubleshooting.
• Support Vendor Change Notification assessments.
• Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
• Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects.
• For example, improvements around tubing management, material kitting, and flow.

Win What we expect of you

We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications:

Basic Qualifications

• High School diploma / GED and 8 years of Engineering or Operations experience
• Associate’s degree and 6 years of Engineering or Operations experience
• Bachelor’s degree and 2 years of Engineering or Operations experience
• Master’s degree

Preferred Qualifications

• Experience with and understanding of Single-Use Systems.
• 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 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.
• Data analysis and/or data visualization skills.
• Excellent writing skills.
• Presentation experience – presentation to leadership.
• Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively.
• Experience in computerized systems for example, Smartsheet, Excel, Trackwise, Veeva, Visio, Lucid Chart.
• Expertise with translating business/user needs to user requirements and recommend solutions.
• Experience in individually supporting key manufacturing systems with 24x7 operations.
• The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations.
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
• Pro‑active, results oriented, and ability to prioritize work to meet timelines.

Thrive What you can expect of us

In addition to the base salary, 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:

• 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.
• 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

Salary Range 86,048.05USD -116,417.95 USD

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.

Join us. careers.amgen.com

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen