Manufacturing Programs Senior Manager: Cleaning Validation

BioSpace; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Annual bonus

Flexible work model

Job summary

Amgen North Carolina is seeking a Manufacturing Programs Senior Manager to lead cleaning validation for both the existing and new Biologics Drug Substance facilities. You will manage cross-functional teams, ensure regulatory compliance, and drive continual improvement across lifecycle phases.

The role requires strong project management, communication, and leadership skills, with a focus on inspection readiness, standard work, and staff development within a Lean/OE framework to boost site

Qualifications

• Doctorate/6+ years biotech ops experience (or equivalent).
• Ability to manage multi-site cleaning validation projects.
• Strong writing and regulatory documentation skills.
• GMP manufacturing and lean/OE experience preferred.
• Experience leading teams and cross-functional collaboration.

Responsibilities

• Lead cleaning validation deliverables across plants.
• Oversee team outputs for quality and regulatory compliance.
• Support troubleshooting, RCAs and CAPA development.
• Develop standard work, inspection readiness tools, and staff training.
• Advance Lean Transformation and OE initiatives for productivity.

Skills

Cross-functional PM

People leadership

Technical writing

GMP manufacturing

Communication skills

Lean manufacturing

Bioprocess knowledge

Education

Doctorate in chemistry/biology/engineering

Master's in chemistry/biology/engineering

Bachelor's in chemistry/biology/engineering

Associates in related field

High school diploma

Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this. Lets change the world. In this vital role you will be part of ANCs 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
• Masters degree in chemistry, biology or engineering & 6years of biotechnology operations experience
• Bachelors degree and 8years of biotechnology operations experience
• Associates degree & 10 years of biotechnology operations experience
• 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.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

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