Job Description
Job Overview:
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Stability Department located in Fargo, ND and will be an onsite position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Control Team and report to the Senior Director of Quality Control responsible for GMP Laboratories and Stability Department
In this role, you will have the opportunity to:
Ensure regulatory compliance of Aldevron stability programs
Provide guidance and support to inter departments for developmental stability programs on new products, technical transfers, and change controls ensuring that expectations are incorporated into stability strategies
Approve and develop stability strategies (for both RG, GMP-S, and GMP) based on regulatory requirements, internal procedures, technical information and historical stability data
Facilitate execution of the established stability strategy across functional areas and across internal and external sites, including stability study initiation, stability sample management, stability storage and stability testing
Strong ability to analyze and interpret stability data, including statistical analysis.
Experience with software tools for data analysis and stability statistical trending
The essential requirements of the job include:
Extensive knowledge of stability testing protocols, methodologies, and regulatory requirements (e.g., ICH guidelines).
Proficiency in analytical techniques such as HPLC, UV-Vis spectroscopy, and other relevant analytical methods.
Familiarity with FDA, EMA, and other international regulatory bodies' requirements and guidelines for stability studies.
Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
Strong ability to analyze and interpret stability data, including statistical analysis.
It would be a plus if you also possess previous experience in:
Experience in a stability testing or quality control role within the pharmaceutical, biotechnology, or related industry.
Proven experience in managing stability studies from inception to conclusion, including protocol development, sample management, and reporting.
Ability to work effectively in a team environment, collaborating with R&D, Quality Assurance, Regulatory Affairs, and other departments.
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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
