Manufacturing Continuous Improvement Lead

uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Place in the Organization

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The department Manufacturing has an important role regarding the quantity and quality of our AAV-based products. cGMP is applied to manufacture and verify the quality of our products to ensure (i) proper delivery and functionality as well as (ii) safety. Those activities are supporting the whole scope of AAV product and process development. By strict application of cGMP guidelines, monitoring and qualification of our manufacturing environment and systems, the manufacturing of drug substance and drug product is performed.

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, QC, QA, Engineering and Validation.

Primary Role:

The individual in this role will be part of a cohesive team located at the uniQure Lexington, MA site. The position will also support the Amsterdam, NE location and occasional travel is necessary. The Manufacturing Continuous Improvement Lead uses expert knowledge of manufacturing practices, human factors & system safety knowledge (aka, human & organizational performance) industrial & process engineering and digital systems to act as a technical leader for the manufacturing team and the sites. The Manufacturing Continuous Improvement Lead will be a key player in the development of system and process operational design, procedures, training manufacturing associates, investigating issues that arise, and driving projects within the team to help drive improved batch flow and success, as measured by Right-First-Time performance and reducing waste.

Key result areas (major duties, accountabilities and responsibilities):

• Applies engineering managment, human factors & system safety, and/or lean methods to promote and implement changes in manufacturing
• Manage projects associated with work flow optimization, mistake-proofing, creating systems error-tolerance, and continuous improvement
• Drive the Tier Meeting governance process, including development of KPIs (both leading and lagging) that can be used to drive performance improvements
• Deploy and mentor leaders on kaizen principles and improvement practices such as use of A3s, kaizen principles, process-mapping, and operational learning at gemba
• Participate on and lead cross-functional teams to drive complex manufacturing operation changes, improvements, and issue investigations
• Provide on-the-floor training of manufacturing staff on human factors & system safety (aka human & organizational performance) and lean methods
• Provide on-the-floor coaching of the manufacturing team in problem reporting, troubleshooting, and problem-solving, to improve both first-order and second-order problem-solving, as well as organizational learning
• Support investigations and own CAPA implementation for manufacturing deviations
• Own and manage change controls for projects within the team

Qualifications:

• Requires BS in a relevant science or engineering discipline (Industrial Engineering, Engineering Management, Human Factors, Ergonomics, or Engineering Psychology strongly preferred) plus 3 years experience in a GMP/GLP environment; or an MS with 1-2 years’ experience; or 10 years professional experience with 5 years’ being in a GMP/GLP environment.
• Background in human factors & systems safety (aka, human & organizational performance)
• Background in lean manufacturing methodologies / operational excellence
• Experience with quality system compliance
• Proficiency in MS Office including, Word, Excel, and PowerPoint

Core competencies:

• Excellent communication and presentation skills
• Skilled in humble inquiry and creating a psychologically safe work environment
• Strong leadership, collaboration, and team building skills
• Skill in conflict resolution and crucial conversations (within the team and between functions)
• Understanding of manufacturing supply chain systems, including production planning, scheduling, and material management
• Proven ability to assess risk and collaborate with support groups to develop suitable action plans and minimize potential impact
• Experience in cGMP inspections (with partner companies and/or regulatory agencies)
• Openness to change and flexible for shifting project priorities
• Work independently with minimal supervision and direction
• Escalate issues and constraints that have the potential to impact business objectives
• Skilled in meeting facilitation and effectiveness
• Intrinsically motivated
• High level of collaboration
• Systems thinking
• Makes data driven decisions