Sr Associate Manufacturing

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.

Sr Associate Manufacturing

Live

What you will do

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

Responsibilities

• Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use SME

• Resolve quick issues and implement 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.

• 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.

• 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.

• Ability to be on-site (flexible worker)

• Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills

• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.

• As Single-use SME:

• Support New Product introduction and projects through SUS mapping

• Support manufacturing and quality through 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.

• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

• High school/GED + 4 years manufacturing and operations experience OR

• Associate's + 2 years manufacturing and operations experience OR

• Bachelor's + 6 months manufacturing and operations experience

• Master's

Preferred Qualifications:

• 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 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

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.

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 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.

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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.