Manager Manufacturing, Single Use Systems & Validation
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Role Summary
Manager Manufacturing, Single Use Systems & Validation
Let’s do this. Let’s change the world. 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.
Responsibilities
- 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.
Qualifications
- 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: Educational background in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field; Experience leading/managing a team of direct reports in a GMP manufacturing environment; Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing; Experience in supporting regulatory submissions, audits, and inspections; Proficient technical writing and presentation skills; Experience in cross-functional project management and operational excellence initiatives; Ability to coach, mentor, and cross-train colleagues within core technical areas; Background in lean manufacturing methodologies and continuous improvement; Knowledge of relevant regulations (e.g., FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH Q7)
Skills
- Technical leadership in single-use systems and cleaning validation
- Quality systems and regulatory compliance
- Cross-functional collaboration and communication
- Training development and staff development
- Lean transformation and continuous improvement