Manufacturing Programs Senior Manager: Cleaning Validation

amgen; Holly Springs (NC); Hybrid; USD 136,000 - 184,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work model

Job summary

Amgen in North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both existing and new biologics DS plants. You will manage cross-functional teams, ensure regulatory compliance, drive improvements, and align with network lessons learned to boost productivity.

The role requires advanced degrees and substantial biotech operations leadership, strong project management, and excellent written and spoken communication.

Qualifications

• Biologics DS manufacturing background with cross-functional PM and communication skills.
• Experience leading teams, projects, or programs in GMP manufacturing.
• Strong technical knowledge of drug substance processing and bioprocessing.

Responsibilities

• Cross-functional collaboration to ensure on-time delivery of cleaning validation deliverables.
• Provides team oversight, ensuring outputs meet quality and regulatory expectations.
• Support Manufacturing in troubleshooting, problem-solving and RCAs; assist CAPA development.
• Establishes Cleaning Validation Program standard work and best practices; align with network.
• Lead Lean Transformation and OE initiatives to improve plant productivity.

Skills

Biologics ops experience

People leadership

Cross-functional collab

Regulatory familiarity

Education

Doctorate in chemistry/biology/engineering

Master’s in chemistry/biology/engineering

Bachelor’s in biotech/engineering

Associate’s + experience

High school + 12y biotech ops

Job description

Career Category

Manufacturing

Job Description

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.

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 disposable 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 Programs Senior Manager: Cleaning Validation

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of ANC’s Manufacturing Support team, and lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This requires managing cleaning validation teams supporting manufacturing plants in different lifecycle phases. It is a highly visible role across the site with the key responsibilities of working cross-functionally to ensure compliance of cleaning validation program to regulatory expectations, driving continual improvement, and maintaining alignment to network lessons learned and best practices. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity.

Responsibilities:

• Cross-functional collaboration to ensure on-time delivery of cleaning validation deliverables.

• Provides team oversight, ensuring outputs meet quality and regulatory expectations.

• Support Manufacturing in troubleshooting, problem-solving and RCAs. Support CAPA development to prevent error recurrence.

• Establishes Cleaning Validation Program standard work and best practices, ensuring network alignment and incorporation of lessons learned. Accountable for inspection readiness strategy and development of inspection readiness tools, standard work, and staff training.

• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

• Doctorate degree in chemistry, biology or engineering & 2 years of biotechnology operations experience or

• Master’s degree in chemistry, biology or engineering & 6years of biotechnology operations experience or

• Bachelor’s degree and 8years of biotechnology operations experience or

• Associate’s degree & 10 years of biotechnology operations experience or

• High school diploma / GED & 12 years of biotechnology operations experience

• AND In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.

• Excellent cross-functional project management, meeting facilitation, and technical writing skills.

• Experience in GMP manufacturing operations.

• Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.

• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

• Ability to effectively 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 areas.

• Background in lean manufacturing methodologies and operational excellence.

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 annual base salary range for this opportunity in the U.S. is provided below.

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.

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.

#AmgenNorthCarolina

.

Salary Range

136,227.80USD -184,308.20USD