Sr Manager QC Microbiology

Amgen; Holly Springs (MS); On-site; USD 142,000 - 192,000; Full time

Benefits offered by this job

Stock-based incentives

Annual bonus

Retirement & Savings Plan

Flexible work options

Job summary

Amgen’s Senior Manager QC Microbiology leads the QC Microbiology organization at Amgen’s Holly Springs site, guiding environmental monitoring, PCR, and microbiology testing to deliver safe medicines. You will develop talent, manage a diverse team, and ensure cGMP compliance across labs and investigations.

You will partner with Quality, Manufacturing, Regulatory, and Technical Development to drive performance, safety, and continuous improvement while upholding Amgen’s commitment to patients and

Qualifications

• High school diploma / GED with 12 years of Quality or Aseptic Manufacturing experience.
• Associate’s degree with 10 years of Quality or Aseptic Manufacturing experience.
• Bachelor’s degree with 8 years of Quality or Aseptic Manufacturing experience.
• Master’s degree with 6 years of Quality or Aseptic Manufacturing experience.
• Doctorate degree with 2 years of Quality or Aseptic Manufacturing experience.
• Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, or resources.

Responsibilities

• Lead the QC Microbiology organization with accountability for safety, quality, compliance, people, and operational performance.
• Oversee environmental monitoring, clean utilities monitoring, microbial identification, PCR, and microbiological testing.
• Build and develop a diverse, high-performing team and strengthen technical capability and succession.
• Ensure laboratory operations comply with cGMP, regulatory expectations, safety standards, and Amgen procedures.
• Provide leadership for investigations, deviations, CAPAs, change controls, trends, and laboratory systems.
• Represent QC Microbiology during regulatory inspections and audits.
• Maintain goals, KPIs, resource plans, and operating mechanisms for reliable lab performance.
• Use data to identify risk and translate complex issues into actions.
• Advance Lean, digital, and continuous improvement in the lab.

Skills

Leadership

People management

Regulatory awareness

Education

Bachelor's degree in a scientific field

Master's degree in Microbiology/Pharmaceutical Sciences

Doctorate in a related field

Tools

PCR

Microbial testing

Environmental monitoring

Job description

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

SR MANAGER QC MICROBIOLOGY

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the Quality Control Microbiology organization at Amgen’s advanced biomanufacturing site in Holly Springs, North Carolina. You will be responsible for the performance and development of a diverse team supporting QC Microbiology and PCR laboratory operations and will play an important role in ensuring the reliable delivery of medicines to patients.

As a member of the Quality Control leadership team, you will provide strategic, technical, and operational leadership across environmental monitoring, clean utilities monitoring, microbial identification, PCR, and microbiological product testing.

This is an opportunity for a strong people and technical leader to shape the future of microbiology at the site—building organizational capability, strengthening laboratory performance, developing talent, and advancing innovation and operational excellence.

• Lead the QC Microbiology organization with accountability for safety, quality, compliance, people, and operational performance.
• Provide oversight for environmental monitoring, clean utilities monitoring, microbial identification, PCR, and applicable in-process, release, stability, and routine microbiological testing.
• Build, coach, and develop a diverse, high-performing team while strengthening technical capability, succession, and career development.
• Ensure laboratory operations comply with cGMP requirements, applicable regulatory expectations, safety standards, and Amgen procedures.
• Provide leadership and technical oversight for investigations, deviations, CAPAs, change controls, trends, validation and qualification activities, methods, and laboratory systems.
• Represent QC Microbiology during regulatory inspections, audits, and other quality oversight activities.
• Maintain meaningful goals, KPIs, resource plans, and operating mechanisms that enable reliable laboratory performance.
• Use scientific and operational data to identify risk, inform decisions, and translate complex issues into clear actions.
• Advance Lean, digital, and continuous improvement approaches that improve laboratory reliability, efficiency, productivity, and cycle time while maintaining uncompromising quality.
• Partner across Quality, Manufacturing, Engineering, Regulatory, Technical Development, and the global Amgen QC network to solve complex problems and strengthen microbiological control strategies.
• Foster a culture where people speak up, challenge assumptions, collaborate across boundaries, and take ownership for results.

How you will lead:

At Amgen, leadership is defined by both what we accomplish and how we accomplish it. As a Senior Manager, you will model Amgen’s values and leadership attributes in how you lead your organization, make decisions, and serve patients.

You will:

• Inspire by connecting people to our mission, developing talent, building trust, and creating an inclusive environment where people can do their best work.
• Accelerate by setting clear priorities, removing barriers, making timely and risk-informed decisions, and acting with the urgency our patients deserve.
• Integrate by connecting people, expertise, and capabilities across functions and the global Amgen network to achieve better outcomes.
• Adapt by anticipating change, remaining curious, challenging established approaches, and helping teams navigate complexity with clarity and confidence.

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 collaborative and inspiring leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR
• Associate’s degree and 10 years of Quality or Aseptic Manufacturing experience OR
• Bachelor’s degree and 8 years of Quality or Aseptic Manufacturing experience OR
• Master’s degree and 6 years of Quality or Aseptic Manufacturing experience OR
• Doctorate degree and 2 years of Quality or Aseptic Manufacturing experience

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:

• Advanced degree in Microbiology, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Leadership experience within a GMP pharmaceutical, biotechnology, or aseptic manufacturing environment.
• Experience leading QC Microbiology, environmental monitoring, clean utilities monitoring, and/or molecular testing operations.
• Strong knowledge of microbiological control, aseptic technique, and cGMP requirements.
• Experience supporting regulatory inspections and interacting with regulatory agencies.
• Demonstrated ability to build, coach, and develop high-performing teams and future leaders.
• Strong scientific judgment and demonstrated ability to translate complex technical data into decisions and actions.
• Demonstrated success driving Lean, continuous improvement, digital transformation, or operational excellence.
• Strong collaboration, influencing, and communication skills, including the ability to work effectively across a global matrixed organization.
• Demonstrated ability to lead through change, challenge the status quo, and create sustainable improvements.

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.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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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Salary Range

142,103.85USD -192,258.15USD