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. Will work with the Director Manufacturing to coordinate plant resources and staff to ensure plant goals/milestones associated with the design, construction, start-up, commissioning, qualification and licensure are met. This position has the broad accountability for all shift responsibilities and personnel as part of a 24x7 manufacturing operation. On shift responsibilities will include managing and scheduling production, maintenance and validation activities. 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 minimal supervision and will be required to leverage experience to exercise judgment in decision making and escalation with regards to operational issues. Responsibilities General:

• Managing the life cycle of the products and validated state of process equipment at Amgen Singapore Biologics manufacturing facility
• 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
• 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

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 capabilities
• Develops strong relationships with staff members, provides open and clear feedback to improve individual and team performance

Delivering financial commitments:

• Planning, developing and maintaining the department budget
• Appropriately allocates resources
• Conducts financial reviews to monitor business performance

Basic Qualifications

• Doctorate degree and 2 years of Process Development or Manufacturing Operations experience OR
• Master’s degree and 6 years of Process Development or Manufacturing Operations experience OR
• Bachelor’s degree and/or 8 years of Process Development or Manufacturing Operations AND
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Advanced Degree in Life Sciences or Engineering
• In depth business understanding of manufacturing or operations in biotechnology, biopharmaceuticals or pharmaceuticals industry
• 8+ years of experience in process development, 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, influencing skills
• Ability to effectively develop and coach staff and team, and positively advance the culture of an organization

Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.