We are hiring a Director of Manufacturing. The Director of Manufacturing manages and directs all activities of manufacturing, production, and coordinating with planning and materials management to ensure all products are produced and delivered on time to inventory to meet quality, customer, and market requirements. Oversees and controls all manufacturing processes and systems. Develops and implements plans, policies, and programs within manufacturing. Work’s cross-functionally to improve quality, safety, and profitability of the organization. They will Work encompasses the broad range of activities required to develop and achieve established objectives within the role. This includes necessary planning, review, and evolution of processes, securing necessary funding and promoting and executing the appropriate strategy for the department. Ensures all processes, procedures, and quality policies comply with QSR, cGMP, ISO 13485, and any other applicable requirements.
Reviews and owns existing plans, policies, and procedures with regard to manufacturing activities. Adjusts these as needed to continually meet production demands, corporate policies, established budgetary guidelines, health and safety of employees, applicable governmental regulations, and emerging technologies.
Develops and implements manufacturing objectives in conjunction with Operational leadership; Develops specific annual and mid-term plans and required budgets.
Reports monthly on status of department, KPI’s and adjustments.
Manages either directly, as needed, but routinely through subordinates manufacturing of catalog and custom products per established procedures, approved specifications, and quality requirements.
Track’s product trends and makes long term recommendations for personnel and equipment planning.
Defines and suggests the procurement, installation and maintenance of processing equipment used in manufacturing.
S. in Engineering, Biology, Chemistry, Operations Management, MBA preferred.
Minimum 10 years of experience in GMP or Medical Device Production, with a minimum of five years of management experience in a cGMP manufacturing environment with multiple levels of direct and indirect reports.
ERP system experience SAP preferred
Knowledge of Budgeting, Planning, P&L Reporting and, Quality Systems.
Detailed knowledge of the processes necessary to produce quality products in a cGMP manufacturing environment.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.