Senior Manager Manufacturing

Career Category

Manufacturing

**Job Description**:
Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

The Senior Manager Manufacturing will be part of the manufacturing team responsible for leading the creation and development of the manufacturing organization and infrastructure associated with the facility. Reporting to the Director of Manufacturing Support, this position is primarily responsible for providing process ownership for multiple biologics products as well as introduction of new biologic products into the manufacturing facility. The scope includes new product introduction, process ownership and leadership, manufacturing finite scheduling, and manufacturing training etc. The role includes the supervision and development of professionals tasked with introduction of new biologic 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 manager will also be responsible for leading operational improvement activities, SOP and electronic batch record updates, closure and management of NC’s, CAPA’s and change controls. The Sr. Manager of Manufacturing will operate under mínimal supervision and will be required to leverage experience to exercise judgment in decision making and escalation with regards to operational issues.

**Responsibilities**:
General:

- Responsible for overseeing all activities of new product introductions and multi-product campaigns in a compliant, agile and cost-effective manner
- Responsible for overseeing all activities associated with managing the validated state of process equipment
- Investigations and associated documentation associated with process deviations/non-conformances
- Provide direct leadership to production interruption investigation and serve as escalation point for resolving process/equipment related issues
- Managing change controls, corrective actions and preventative actions associated with products and process equipment
- Managing the implementation and development of the electronic batch records
- Develop a high performing team, build technical and leadership capabilities within the organization to meet current and future business needs
- Drive a culture of continuous improvement
- Drive/support site wide technical and non-technical continual improvement initiatives, programs and projects to increase production and disposition agility
- Present key investigations and quality management system records in all site regulatory inspections
- Ensure alignment of scheduling and training strategies to meet manufacturing execution needs
- Drive improvement plant capacity and build a sustainable capacity modelling/training model

Leading strategy development and execution:

- 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
- Deliver strong business results
- Lead and/or support Amgen global network initiatives

Building a strong organizational alignment:

- 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
- Ensure effective decision-making and clear and timely communication

Attracting, developing and retaining diverse talent:

- Builds and develops a diverse, high performing team
- Conducts short
- and long-range talent planning to ensure readiness of talent to execute future organizational objectives
- Establishes an efficient and effective organizational structure with clearly defined roles and responsibilities
- Works across functions to build organization and individual capabili