Manufacturing Programs Senior Manager: Cleaning Validation

Amgen Inc.; Holly Springs (NC); On-site; USD 136,000 - 184,000; Full time

Benefits offered by this job

Remote work arrangements

Stock-based incentives

Job summary

Amgen Inc. in North Carolina is seeking a Manufacturing Programs Senior Manager: Cleaning Validation to lead cross-functional teams across two biologics DS plants.

You will drive cleaning validation delivery, ensure compliance with regulatory expectations, and advance continuous improvement within the ANC network. Ideal candidates bring biotech manufacturing validation experience, strong project management, and a track record of leading teams through complex regulatory programs.

Qualifications

• Doctorate in chemistry, biology or engineering with biotechnology ops experience or
• Master’s in chemistry, biology or engineering with biotechnology ops experience or
• Bachelor’s with biotechnology ops experience or
• Associate’s with biotechnology ops experience or
• HS diploma with biotechnology ops experience

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.
• Establishes Cleaning Validation Program standard work and best practices; ensure inspection readiness.
• Champions Lean Transformation and OE initiatives; track plant-level progress.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Quality improvement

Education

PhD in Chemistry/Biology/Engineering

MS in Chemistry/Biology/Engineering

BS in Chemistry/Biology/Engineering

AS/AA in related field

HS diploma

Tools

GMP familiarity

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 toward 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 & 6 years of biotechnology operations experience or
• Bachelor’s degree and 8 years 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.

Objects in your future are closer than they appear.

Join us.

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 -184,308.20 USD