Manufacturing Senior Associate Single Use Systems (SUS)

BioSpace; Holly Springs (NC); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Health and welfare benefits

Flexible work models

Job summary

Amgen North Carolina in Holly Springs is seeking a Manufacturing Senior Associate focused on Single Use Systems (SUS) within the drug substance organization. You will support SUS mapping, SOP maintenance, and investigations on the floor to ensure smooth operations.

The role emphasizes collaboration with CI leads and cross-functional teams. We expect strong data analysis, excellent written and verbal communication, and the ability to drive improvements in a fast-paced manufacturing environment.

Qualifications

• High School diploma / GED with 8 years of Engineering or Operations experience.
• Associates degree with 6 years of Engineering or Operations experience.
• Bachelor's degree with 2 years of Engineering or Operations experience.
• Masters degree

Responsibilities

• Support New Product introduction and projects through SUS mapping/drawing.
• Maintain and edit SUS Standard Operating Procedures (SOP).
• Support manufacturing and quality through SUS defect/leak triage and investigations.
• Initiate EN/SICAR records and collaborate with vendors on investigations.
• Maintain EN/SICAR/Early Engagement trackers and manage small to medium projects.
• Provide input for ANC representative to SUS network for improvements.
• Support Vendor Change Notification assessments.
• Understand single-use material capabilities for new technologies.
• Collaborate with CI leads on SUS improvement projects and use cases.

Skills

Data analysis

Data visualization

Excellent writing

Presentation to leadership

Cross-functional collaboration

Project management

Education

Bachelor's degree in Engineering or Operations

Master's degree

Associates degree

Tools

Smartsheet

Excel

Trackwise

Veeva

Visio

Lucidchart

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its 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

Lets do this. Lets change the world. In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuousimprovement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolinas success and key in supporting single-use (SUS) operations.

Key Responsibilities Include

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. 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
• OR
• Associates degree and 6 years of Engineering or Operations experience
• OR
• Bachelors degree and 2 years of Engineering or Operations experience
• OR
• Masters 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.
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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.

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

• 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

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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