The Director Manufacturing is responsible for leading all production operations at a single manufacturing facility. Manages and coordinates plant resources and personnel to ensure product quality standards and production schedules are met within budgeted costs. May also responsible for the production of commercial, clinical or finished product. This role is crucial for Amgen’s success and it will be a key contributor in the Inspection, Assembly & Packaging area. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Direct the Inspection, Assembly and Packaging manufacturing facility. Responsible for management and oversight of one or more manufacturing production areas. Ensures that clinical and licensed products manufactured at production facility are produced according to current Good Manufacturing Practices (cGMP) and other applicable regulations from international countries. Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations. Ensures that written procedures describing the manufacturing operations are accurate, approved, and implemented. Ensures production activities follow approved cGMP procedures and are documented according to cGMP requirements. Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, identity and effectiveness of the product(s) manufactured. Ensures that there is an adequate number of personnel who possess an adequate combination of education, experience and training in accordance with cGMP requirements. Ensures that area staff are trained to perform assigned production activities. Ensures that non-conformances are reported promptly to the Quality unit and investigated per procedures. Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures. Ensures that the requirements of the Quality Management System are fulfilled. Alerts senior management of significant quality, compliance, supply and safety risks. Provides input for Management Reviews. Leads the preparation of the Business Reviews. Ensures that the manufacturing activities comply with established OEE targets. Responsible for OEE in the plant. Responsible for the implementation of Lean Manufacturing and Operational Excellence initiatives in the production floor. Responsible to maintain adequate manufacturing resources, human and physical asset capacity, to support customer demand. Responsible for planning and maintaining budget for assigned areas. Collaborates with cross-functional teams in completing production activities. Supports Continual Improvement initiatives, programs and projects. Support non-standard shift organization including extended hours, as per business needs. Leads others in identifying business process improvements. Develops insightful strategies for staff development that are shared and adopted at site or network level. Builds empowered teams. Identify and advocate new technologies that could have a significant impact across the network. Leads others in identifying risks and the necessary actions for mitigation. Lead and coach of others around the risk management principles during decision making. Understands, applies and coaches others around the use of the DAI model during decision making processes. Can execute and coach others on all roles within the DAI model. Uses advanced DAI tools (e.g. private collection) and seeks for and foments the generation of dis-confirming information during decision making. Promotes a culture that strives and looks for improvement opportunities as a change agent at the network level. Takes a leadership role with senior management to set strategic priorities that have a business impact across the network. BASIC EDUCATION & EXPERIENCE Doctorate degree and 4 years of Manufacturing experience within the biotechnology, pharmaceutical or medical device industry OR Master’s degree and 8 years of Manufacturing experience within the biotechnology, pharmaceutical or medical device industry OR Bachelor’s degree and 10 years of Manufacturing experience within the biotechnology, pharmaceutical or medical device industry AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. PREFERRED QUALIFICATIONS In-depth knowledge of parenteral drug product inspection and packaging operations. In-depth knowledge of solid dosage operations. Decision making and influencing skills. Ability to manage a large number of complex projects simultaneously. Previous interactions with regulators both verbally and in writing. Demonstrated proficiency in leading Lean Transformations across several functional areas. Advanced knowledge of US and International regulations and practices pertaining to the manufacture and testing of pharmaceutical/biological products. General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of bio-pharmaceuticals. Understanding of bio-pharmaceutical bulk and drug product manufacturing and distribution processes. Understanding of production planning and supply chain operations in the bio-pharmaceutical finished product industry. Ability to perform at Site Head level-through knowledge of GMP practices and international equivalents. Ability to demonstrate leadership and team building. Conflict resolution oriented. Analytical problem solving, negotiation, project management, coaching, mentoring and counseling skills. Be flexible and manage changes. Excellent presentation skills Skills in principle and applications of validation processes. Excellent oral and written communication skills (English and Spanish). Demonstrate written skills that are on par with professional journals, global industry groups, and professional associations. Computer Knowledge (MS Word, Excel, PowerPoint, Maximo). Demonstrated/potential skills and competencies in the following: Negotiating skills Overall understanding of mechanical systems Budgeting Goal setting Capacity Planning/Inventory Understanding of Manufacturing/Pharma Business
