Manager Manufacturing Programs – Investigations
Amgen
Manager Manufacturing Programs – Investigations
Job Description
Career CategoryManufacturingJob DescriptionHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. 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 single use 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. Manager Manufacturing Programs – InvestigationsLive What you will do Let's do this. Let's change the world. In this vital leadership role, you will lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement. Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations. Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations. Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem-solving discussions. Manage team priorities, workload balancing, resource planning, and performance management. Provide technical oversight of manufacturing and environmental monitoring investigations. Drive consistency in root cause analysis and CAPA development. Serve as site subject matter expert for Environmental Monitoring related investigations. Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development. Lead escalation and governance for deviations. Support and present during regulatory inspections and internal audits. Monitor investigation metrics and drive continuous improvement. Champion Operational Learning Team principles and organizational learning. Develop investigation procedures, standards, and training. Build a culture of accountability, inclusion, and operational excellence. Win What we expect of you The collaborative leader we seek has extensive biologics drug substance manufacturing experience with demonstrated success leading technical teams, driving cross-functional collaboration, and improving quality systems. Basic Qualifications Doctorate degree Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma/GED and 12 years of directly related experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience. 0-2 years of people leadership or technical leadership. Strong knowledge of GMPs, contamination control, and environmental monitoring. Expertise leading investigations and root cause analysis. Degree in Science or Engineering (Microbiology or similar a plus). Experience with Veeva QMS or equivalent quality systems. Experience supporting FDA and global regulatory inspections. Strong communication, coaching, and organizational leadership skills. Thrive The annual salary range for this opportunity in the U.S. is [HR to input market pay range]. In addition to base salary, Amgen offers a comprehensive Total Rewards package including health and welfare benefits, retirement savings, annual bonus opportunity, stock-based long-term incentives, generous paid time off, company shutdowns, and career development opportunities. .Salary RangeUSD - USD
Locations
- US - North Carolina - Holly Springs
Skills Required
- GMPsintermediate
- Veeva QMSintermediate
Required Qualifications
- Doctorate degree (degree)
- Doctorate degree (degree)
- Master's degree and 3 years of directly related experience (experience, 3 years)
- Master's degree and 3 years of directly related experience (experience, 3 years)
- OR Bachelor's degree and 5 years of directly related experience (experience, 5 years)
- OR Bachelor's degree and 5 years of directly related experience (experience, 5 years)
- OR Associate's degree and 10 years of directly related experience (experience, 10 years)
- OR Associate's degree and 10 years of directly related experience (experience, 10 years)
- OR High school diploma/GED and 12 years of directly related experience (experience, 12 years)
- OR High school diploma/GED and 12 years of directly related experience (experience, 12 years)
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above (experience)
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above (experience)
Preferred Qualifications
- 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience. (experience, 5 years)
- 5+ years of biologics manufacturing, microbiology, quality, or related pharmaceutical experience. (experience, 5 years)
- 0-2 years of people leadership or technical leadership. (experience, 2 years)
- 0-2 years of people leadership or technical leadership. (experience, 2 years)
- Strong knowledge of GMPs, contamination control, and environmental monitoring. (experience)
- Strong knowledge of GMPs, contamination control, and environmental monitoring. (experience)
- Expertise leading investigations and root cause analysis. (experience)
- Expertise leading investigations and root cause analysis. (experience)
- Degree in Science or Engineering (Microbiology or similar a plus). (degree in science or engineering)
- Degree in Science or Engineering (Microbiology or similar a plus). (degree in science or engineering)
- Experience with Veeva QMS or equivalent quality systems. (experience)
- Experience with Veeva QMS or equivalent quality systems. (experience)
- Experience supporting FDA and global regulatory inspections. (experience)
- Experience supporting FDA and global regulatory inspections. (experience)
- Strong communication, coaching, and organizational leadership skills. (experience)
- Strong communication, coaching, and organizational leadership skills. (experience)
Responsibilities
- Let's do this. Let's change the world. In this vital leadership role, you will lead the Manufacturing Investigations team supporting the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will develop a high-performing team that conducts timely, thorough, and compliant deviation investigations while driving operational excellence, inspection readiness, and continuous improvement.
- Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
- Lead, develop, coach, and mentor a team of Manufacturing Investigation Specialists specializing in simple deviation and environmental monitoring investigations.
- Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
- Apply advanced understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
- Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem-solving discussions.
- Create an environment of trust and psychological safety where team members feel empowered to raise concerns, challenge assumptions, share diverse perspectives, and contribute openly to problem-solving discussions.
- Manage team priorities, workload balancing, resource planning, and performance management.
- Manage team priorities, workload balancing, resource planning, and performance management.
- Provide technical oversight of manufacturing and environmental monitoring investigations.
- Provide technical oversight of manufacturing and environmental monitoring investigations.
- Drive consistency in root cause analysis and CAPA development.
- Drive consistency in root cause analysis and CAPA development.
- Serve as site subject matter expert for Environmental Monitoring related investigations.
- Serve as site subject matter expert for Environmental Monitoring related investigations.
- Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
- Lead cross-functional partnerships across Manufacturing, Quality, Engineering, Automation, EHSS, and Process Development.
- Lead escalation and governance for deviations.
- Lead escalation and governance for deviations.
- Support and present during regulatory inspections and internal audits.
- Support and present during regulatory inspections and internal audits.
- Monitor investigation metrics and drive continuous improvement.
- Monitor investigation metrics and drive continuous improvement.
- Champion Operational Learning Team principles and organizational learning.
- Champion Operational Learning Team principles and organizational learning.
- Develop investigation procedures, standards, and training.
- Develop investigation procedures, standards, and training.
- Build a culture of accountability, inclusion, and operational excellence.
- Build a culture of accountability, inclusion, and operational excellence.
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