Sr. Manager Method Validation
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Job Summary
Sr. Manager Analytical Method Validation
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.
The Sr. Manager Analytical Method Validation position is responsible for leading Aldevrons analytical method validation program to ensure robust compliant and scientifically sound methods for plasmid DNA mRNA and related biologics. This role oversees method development support validation transfer and lifecycle management in alignment with global regulatory requirements
This position reports to the Sr. Director Quality Control and is part of the Quality Regulatory Affairs department located in Fargo ND and will be an on-site role.
In this role you will have the opportunity to:
- Oversee Aldevrons Method Validation program and personnel ensuring compliance with established SOPs for analytical method qualification validation transfer and lifecycle management.
- Provide leadership and mentorship to validation teams fostering a high-performance culture through coaching development and effective performance management.
- Direct and oversee multiple validation projects simultaneously ensuring timely execution resource allocation and alignment with organizational priorities.
- Ensure strong interaction with multiple groups to facilitate appropriate resource allocation and scheduling of method validation and transfer activities.
- Serve as the subject matter expert for inspections and audits; defend validation strategies and ensure compliance with data integrity standards.
- Approve validation documentation and monitor method performance trends to ensure compliance and reliability.
- Lead structured problem-solving and continuous improvement initiatives using visual management and standard work principles to optimize method performance and maintain lifecycle control.
The essential requirements of the job include:
- Bachelors degree in Analytical Chemistry Biochemistry Molecular Biology or related field (Masters or PhD preferred).
- 8 years in GMP biopharma/biotech analytical development/validation
- 5 years of proven leadership experience managing teams in a GMP environment
- Comprehensive understanding of global regulatory expectations for analytical methods in GMP environments including principles for validation verification and lifecycle management
It would be a plus if you also possess previous experience in:
- Experience driving continuous improvement initiatives using data analytics to enhance method performance reduce variability and improve efficiency.
- Experience in developing implementing and maintaining key departmental metrics to monitor performance drive accountability and support continuous improvement initiatives.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.
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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.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Manager
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
