What are the responsibilities and job description for the Stability Program Manager position at Aldevron, L.L.C.?
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 Quality Control and may be located in Fargo, ND or Madison, WI. 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 Stability team and report to the Senior Director of Quality Control.
In this role, you will have the opportunity to:
Lead, mentor, and develop a team of Stability Specialist
Ensure timely and accurate Stability documentation, including protocols, timelines and summary reports.
Develop, implement, and manage stability programs in accordance with regulatory requirements (e.g., ICH guidelines) and company policies.
Implement and maintain Stability department standard operating procedures.
Manage stability projects from inception to completion, ensuring timelines and milestones are meet.
Collaborate with cross-functional teams, including Quality Assurance, Tech Ops, and Regulatory Affairs.
The essential requirements of the job include:
Bachelor’s degree in Scientific/ Technical related field required
Minimum of 3-5 years of GMP experience, preferably in a Life Sciences/CDMO industry.
1 year of supervisory/leadership experience.
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:
Knowledge of root cause analysis tools and risk management tools (5 whys, 6M etc..) in a compliance industry
Proficiency in laboratory information systems (LIMS)
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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Join our winning team today. Together, we’ll 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.
For more information, visit www.danaher.com.
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