Sr. Manager, Drug Product Finishing Operations

Danaher•Fargo, ND

6d•Onsite

About The Position

The Sr. Manager, Drug Product Finishing Operations leads Aldevron’s post-fill Drug Product Finishing capability, including Visual Inspection, labeling, and future packaging, serialization, semi-automated inspection, and related operations. This position reports to the Vice President, Manufacturing responsible for GMP Production, is part of the Manufacturing department, and is an on-site role. In this role, you will have the opportunity to Build and scale the Finishing Operations strategy, organization, operating model, capacity plan, and capability roadmap, including future packaging, serialization, automated inspection, ID grading, kitting, final assembly, and expanded labeling capabilities. Lead Finishing leaders, inspectors, trainers, and support roles; establish hiring, training, qualification, requalification, performance, succession, and retention plans. Own daily execution, staffing, scheduling, shift coverage, area and equipment readiness, product flow, reconciliation, documentation completion, material status, staging, handoffs, chain of custody, and time-out-of-temperature tracking. Lead Visual Inspection as a dedicated capability and transition labeling execution into Finishing while preserving independent Quality controls. Define user requirements and support capital projects, vendor selection, qualification, validation, maintenance, calibration, technology transfer, and operational handoff. Assess new products, formats, and technologies for inspect ability, labeling, packaging, defect-kit readiness, equipment fit, staffing, cycle time, sample needs, and operational risk. Support deviations, investigations, corrective and preventive actions, change controls, risk assessments, audits, regulatory inspections, client discussions, readiness reviews, metrics, budgets, resource priorities, and continuous improvement.

Requirements

Bachelor’s degree in life sciences, engineering, operations, business, or a related field.
10 or more years of progressive experience in pharmaceutical or biologics manufacturing, operations, quality, engineering, validation, or a related technical function, including Drug Product finishing or execution.
2 or more years of leadership experience managing people, major programs, or cross-functional implementation. Experience indirectly leading and influencing associates and leaders outside of their span of control will be a critical skill.
Experience with Visual Inspection and at least one related Drug Product finishing capability, such as labeling, packaging, serialization, ID grading, or release readiness.
Experience standing up or expanding facilities, equipment, or capabilities through qualification, validation, and commercial handoff.
Experience with batch readiness, material handoffs, chain of custody, product status, storage and transport controls, time-out-of-temperature management, and compliant documentation or data-integrity controls.
Experience leading investigations, corrective and preventive actions, change controls, risk assessments, and continuous improvement in a current Good Manufacturing Practice environment.

Nice To Haves

An advanced degree in life sciences, engineering, operations, business, or a related field.
FDA and EMA inspections, client audits, and DEA requirements when controlled substances are in scope.
A contract development and manufacturing organization supporting products from early clinical development through commercial readiness.

Responsibilities

Build and scale the Finishing Operations strategy, organization, operating model, capacity plan, and capability roadmap, including future packaging, serialization, automated inspection, ID grading, kitting, final assembly, and expanded labeling capabilities.
Lead Finishing leaders, inspectors, trainers, and support roles; establish hiring, training, qualification, requalification, performance, succession, and retention plans.
Own daily execution, staffing, scheduling, shift coverage, area and equipment readiness, product flow, reconciliation, documentation completion, material status, staging, handoffs, chain of custody, and time-out-of-temperature tracking.
Lead Visual Inspection as a dedicated capability and transition labeling execution into Finishing while preserving independent Quality controls.
Define user requirements and support capital projects, vendor selection, qualification, validation, maintenance, calibration, technology transfer, and operational handoff.
Assess new products, formats, and technologies for inspect ability, labeling, packaging, defect-kit readiness, equipment fit, staffing, cycle time, sample needs, and operational risk.
Support deviations, investigations, corrective and preventive actions, change controls, risk assessments, audits, regulatory inspections, client discussions, readiness reviews, metrics, budgets, resource priorities, and continuous improvement.