Senior Manager Manufacturing Programs

Senior Manager Manufacturing Programs

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Manager Manufacturing Programs in Amgen Singapore Manufacturing.

Live

What you will do

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.

Main Responsibilities:

General:

• 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

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
• Delivers strong business results
• Leads and/or supports 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
• Ensures effective decision-making and clear and timely communication

Attracting, developing and retaining diverse talent:

• 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

Delivering financial commitments:

• Plans, develops and maintains the department budget
• Appropriately allocates resources
• Conducts financial reviews to monitor business performance

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Win

What we expect of you

Basic Qualifications

• 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. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.