Senior Associate Manufacturing

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 downstream processes as 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

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.

Sponsorship

Sponsorship for this role is not guaranteed.

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Salary Range