Manager Manufacturing Single Use Systems - Holly Springs, NC bei Amgen
Amgen · Holly Springs, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Holly Springs
Job Description
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.
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.
Job_Category
Minimum Education Required
City*
Additional Qualifications/Responsibilities
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 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).
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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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
114,259.00 USD - 133,764.00 USD
