Sr. Manager Method Validation

Leica Microsystems • North River, ND

3d • Onsite

About The Position

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 Aldevron's 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 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.

Requirements

• 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

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees