Position Title: Manager, Manufacturing
Summary (Scope of Job):
Responsible for directing personnel and operations involved in the development and commercial manufacturing of Enable’s drug delivery platforms. Responsibilities include budgeting, scheduling, enhancement of quality and safety performance, cost reductions, process improvements, manufacturing clean room and performance reviews.
· Device assembly, clean room controls, personnel management and quality related experience required.
· Proven success managing both people and projects.
· Technical degree with seven to fifteen years related experience in a cGMP/regulated pharmaceutical, medical device, biotechnology or combination product industry.
· Experience in medical device development, company start-up and regulatory inspection of manufacturing plant preferred.
Skills & Competencies:
· Familiarity with GxP regulatory compliance regulations.
· Project planning, organizing and communication. Independent and responsive to input, diplomacy and persuasion, ability to find common ground and resolution.
· Desire to be a team player is required.
· Recruit and manage staff to execute department functions; ensure effective utilization of resources through consistent performance management and recognize practices in area of responsibility.
· Provides leadership, guidance and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards.
· Partner with Development, Materials Management, Program Management or Human Factors, as appropriate, to ensure accuracy of and adherence to area production schedules.
· Ensure that appropriate levels of trained resources are available to meet production schedules.
· Proactively identify, assess and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams.
· Support management in developing department budget.
· Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
· Ensure staff has appropriate knowledge of department processes and procedures to perform job responsibilities.
· Ensures manufacturing work instructions and production records reflect current practice, are aligned to cGMPs and corporate standards.
· Ensure Inspection readiness of manufacturing areas.
· Provide manufacturing approval of department documentation changes.
· Participate in inspections and audits conducted by external regulators.
· Identify opportunities to improve manufacturing processes and practices.
· Partner with cross-functional groups to troubleshoot and drive resolution of operational issues and proactively drive continuous improvement projects to completion.