Manager Manufacturing, Single Use Systems & Validation

Amgen•Holly Springs, NC

23h

About The Position

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. 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. 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, Single Use Systems & Validation What you will do 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.

Requirements

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

Nice To Haves

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 to communicate complex information effectively with technical and senior management staff.
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).

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.