Aldevron · 2 weeks ago
Sr. Manager Method Validation
Fargo, ND
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
8+ years expAldevron is a leading company in the Life Sciences sector focused on advancing science in meaningful ways. The Sr. Manager Analytical Method Validation is responsible for leading the analytical method validation program, ensuring compliance with global regulatory requirements and overseeing method development, validation, transfer, and lifecycle management.
BiotechnologyCommercialIndustrialManufacturing
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 (Master's 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
Preferred
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
Aldevron
Aldevron is a biological development and manufacturing organization specializing in cell and genetic engineering.
1001-5000 employees
H1B Sponsorship
Aldevron 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (8)
2023 (10)
2022 (6)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
TA Associates
2021-06-17Acquired
2019-01-01Private Equity
2017-01-24Private Equity
Leadership Team
Kevin Ballinger
Chief Executive Officer
Nathan Spangler
Senior Director, IVT mRNA Services Platform
Recent News
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