Danaher Corporation · 2 weeks ago
Sr. Manager Method Validation
Fargo, North Dakota, United States
Full-time
Onsite
Director/Executive
8+ years expAldevron, a company under Danaher Corporation, is dedicated to advancing science in meaningful ways. The Sr. Manager Analytical Method Validation will lead the analytical method validation program, ensuring compliance and scientific soundness of methods for plasmid DNA, mRNA, and related biologics.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Oversee Aldevron’s 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
Qualification
Required
Bachelor's degree in Analytical Chemistry, Biochemistry, Molecular Biology, or related field
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
Preferred
Master's or PhD in Analytical Chemistry, Biochemistry, Molecular Biology, or related field
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
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
H1B Sponsorship
Danaher Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
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