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Reporting to the Director of Manufacturing Support, this position is responsible for providing process ownership for multiple biologic/synthetic products as well as introduction of new products into the manufacturing facility. The scope includes process (including single use) ownership and leadership, contamination control, inspection readiness, new product/technology introduction, MES, Validation and scheduling. The role includes the supervision and development of professionals tasked with introduction of new molecules, managing, planning and implementation of changes, driving deviation investigations, resolving process interruptions, etc. This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network. The senior manager will also be responsible for leading operational improvement activities, SOP and electronic batch record updates, closure and management of deviations, CAPA and change controls. The Sr. Manager will operate under minimal supervision and will be required to leverage experience to exercise judgment in decision making and escalation with regards to operational issues.
Job Responsibility
Responsible for providing process ownership for multiple biologic/synthetic products as well as introduction of new products into the manufacturing facility
Responsible for overseeing all activities of new product/technology introductions and multi-product campaigns in a compliant, agile and cost-effective manner
Responsible for overseeing all activities associated with cleaning validation and managing the validated state of process equipment
Responsible for contamination control and inspection readiness for manufacturing
Provides direct leadership to production interruption investigation and serve as escalation point for resolving process (including single use)/equipment related issues
Manages deviations, change controls, corrective actions and preventative actions associated with products and process equipment
Manages the implementation and development of the electronic batch records
Drives a culture of continuous improvement
Drives/supports site wide technical and non-technical continual improvement initiatives, programs and projects to increase production and disposition agility
Presents key investigations and quality management system records in site regulatory inspections
Responsible for overseeing scheduling activities to meet manufacturing execution needs and drive plant capacity improvement
Develops and implements departmental strategy and plans that are aligned with the broader organizational strategy
Champions cultural transformation and institutionalizes changes in process, practices, business models, governance, etc.
Anticipates risk and builds contingencies to help mitigate impact
Delivers strong business results
Leads and/or supports Amgen global network initiatives
Demonstrates personal credibility and build strong working relationships, breaks barriers and influences across organizational and/or geographical boundaries to achieve highly efficient and reliable organizational performance
Ensures the right people and resources are in place and optimally allocated to achieve results
Creates an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing
Ensures effective decision-making and clear and timely communication
Develops a diverse, high performing team, builds technical/leadership capabilities and conducts talent planning within the organization to meet current and future business needs
Establishes an efficient and effective organizational structure with clearly defined roles and responsibilities
Works across functions to build organization and individual capabilities
Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance
Plans, develops and maintains the department budget
Appropriately allocates resources
Conducts financial reviews to monitor business performance
Requirements
Doctorate degree and 2 years of Process Development, Engineering or Manufacturing experience OR Master’s degree and 6 years of Process Development, Engineering or Manufacturing experience OR Bachelor’s degree and/or 8 years of Process Development, Engineering or Manufacturing experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
In depth business understanding of manufacturing or operations in biotechnology, biopharmaceuticals or pharmaceuticals industry
8+ years of experience in process development, engineering, manufacturing technical support or manufacturing operations
6+ years of leadership experience with two or more years as a cross-functional team leader including experience in performance management, technical problem solving, and managing projects (or equivalent/lateral experience)
4+ years of experience operating in a cGMP environment
Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
Ability to recommend, judge, and make good decisions in complex situations
Ability to responsibly and professionally address difficult business and personnel issues
manage conflict effectively with demonstrated negotiating, partnering and influencing skills
Ability to effectively develop and coach staff and team, and positively advance the culture of an organization
Your selection for this role will be subject to fulfilling the medical requirements of this job scope
What we offer
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits