Specialist 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.

Specialist 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

• 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.

• As Process owner:

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

• Provide assessment and advice on process impact for changes

• 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 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.

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:

Doctorate degree

Or

Master's degree and 2 years of manufacturing and operations experience

Or

Bachelor's degree and 4 years of manufacturing and operations experience

Or

Associate's degree and 8 years of manufacturing and operations experience

Or

High school diploma / GED and 10 years of [manufacturing and operations experience

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 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

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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Application deadline

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.