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.
The essential requirements of the job include:
• 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.
Travel, Physical & Environment Requirements
• Ability to travel as required for vendor, client, facility, and business needs.
• Ability to routinely work in Drug Product and Finishing areas, including cleanrooms or controlled areas requiring personal protective equipment and gowning, and near refrigerated or temperature-controlled product.
• Ability to see, talk, hear, sit, stand, walk for extended periods, use computers and manufacturing systems, and occasionally lift or move up to 25 pounds.
• Ability to occasionally support operations outside normal business hours.
Reasonable accommodations may be made as required.
It would be a plus if you also possess previous experience in:
• 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.
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
