Sr. Manager, Drug Product Finishing Operations (Biotech Manufacturing)

Location: Fargo, North Dakota, United States; on-site role

Company

Aldevron is a hirify.global operating company providing CDMO services that support the development and manufacturing of genomic medicine products.

What you will do

• Build and scale the Drug Product Finishing strategy, organization, operating model, capacity plan, and capability roadmap.
• Lead visual inspection, labeling, packaging, serialization, automated inspection, ID grading, kitting, and final assembly operations.
• Manage Finishing leaders, inspectors, trainers, and support staff, including hiring, training, qualification, performance, and succession planning.
• Own daily execution, staffing, scheduling, shift coverage, equipment readiness, product flow, reconciliation, documentation, material status, handoffs, and chain of custody.
• Define user requirements and support vendor selection, qualification, validation, maintenance, technology transfer, and operational handoff.
• Lead investigations, CAPAs, change controls, risk assessments, audits, regulatory inspections, metrics, budgets, and continuous improvement.

Requirements

• Bachelor’s degree in life sciences, engineering, operations, business, or a related field.
• At least 10 years of progressive experience in pharmaceutical or biologics manufacturing, operations, quality, engineering, validation, or a related technical function, including Drug Product finishing or execution.
• At least 2 years of leadership experience managing people, major programs, or cross-functional implementations.
• Experience with visual inspection and at least one additional finishing capability, such as labeling, packaging, serialization, ID grading, or release readiness.
• Experience expanding facilities, equipment, or capabilities through qualification, validation, and commercial handoff.
• Ability to work in cleanrooms or controlled areas with PPE and gowning, support occasional work outside normal hours, travel as required, and lift or move up to 25 pounds.

Nice to have

• Advanced degree in life sciences, engineering, operations, business, or a related field.
• Experience with FDA and EMA inspections, client audits, or DEA requirements.
• Experience working for a CDMO supporting products from early clinical development through commercial readiness.

Culture & Benefits

• Mission-driven work supporting life sciences, diagnostics, biotechnology, and genomic medicine.
• Benefits include healthcare programs and paid time off.
• Continuous improvement is supported through the hirify.global Business System.
• Reasonable accommodations are available for qualified candidates and employees.