Manager Manufacturing Single Use Systems - Holly Springs, NC

Manager Manufacturing Single Use Systems - Holly Springs, NC

In this vital role, you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. In this vital role, you will act as the Manager for Single Use Systems and Cleaning Validation, leading a team responsible for the oversight, implementation, and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations, process development, engineering, supply chain, and quality.

Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area. Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation. Lead development and execution of the site's Cleaning Validation Master Plan (CIP / SIP / COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols / reports, and cleaning validation strategies. Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development. Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility. Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions. Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections. Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant. Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies. Develop and implement training plans and programs to ensure staff are prepared and compliant. Maintain inspection readiness and support staff with audit or regulatory response strategy.

Basic Qualifications :

• High school diploma / GED and 12 years of biotechnology operations or validation experience OR
• Associate's degree and 10 years of biotechnology operations or validation experience OR
• Bachelor's degree and 5 years of biotechnology operations or validation experience OR
• Master's degree and 3 years of biotechnology operations or validation experience OR
• Doctorate degree

Preferred Qualifications :

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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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.