Career Category

Job Description

Amgen continues to grow and evolve in the JAPAC region and now has two complementary manufacturing plants in Singapore – our Next Generation Bioprocessing plant and our first ever Synthetic Drug Substance plant. We are recruiting a Director of Manufacturing to support the latter facility. The Director of Manufacturing will be responsible for leading the manufacturing organization, overseeing day to day operations, and ensuring production milestones are met in a safe and compliant manner.

Responsibilities

Compliance:

• Ensure production area, process and procedures are maintained in full current Good Manufacturing Practices (cGMP) and inspection ready compliance.
• Approve, establish and ensure practices and policies that are consistent within the manufacturing organization and company.
• Represent the plant and manufacturing operations to regulatory authorities. 
• Interact with site efforts to ensure consistency in policies and practices.

Production: 

• Responsible to maintain a safe environment where staff, support groups, and visitors adhere to plant safety procedures.
• Responsible for maintaining a reliable manufacturing unit where production demands are met.
• Lead manufacturing teams to achieve plant production goals and objectives.
• Monitor and / or initiate the development and implementation of plant improvement projects and efficiency exercises.
• Troubleshoot and resolve production issues, leverage in-silico process modeling to elucidate operations.
• Direct area production scheduling, capacity analysis, and agility initiatives.
• Responsible for ensuring that risks are identified and assessed to ensure the safety, purity, quality, and effectiveness of the products manufactured.
• Identify, document, and mitigate risks for the operation.
• Hands-on champion for Lean Manufacturing, Continuous Improvement, and Productivity initiatives.

Planning:

• Establish and communicate area manufacturing goals and objectives consistent with the business strategy.
• Ensure products and services are aligned with current and future needs and expectations.
• Provide authoritative advice to top management based on deep subject matter expertise.
• Use resource model to guide finite scheduling.

Staff:

• Coach and ensure the development of management and staff and evolving a culture aligned with the concepts of Great Place to Work.
• Partner with HR to ensure recruiting, retaining, coaching and motivating staff as a differentiating and competitive advantage.
• Ensure an on-going organizational structure capable of adapting to changing business needs.
• Ensure plant safety goals are communicated and supported with on-going plant safety programs.
• Ensure required initial and continuing training for the operations department personnel is carried out and adapted according to needs.
• Demonstrated ability in emotional intelligence, cultural and situational awareness, and responsible for organizational long-term development and succession plans.
• Responsible for ensuring an environment and culture of Continuous Improvement.

Support Functions:

• Collaborate with, and serve as plant level liaison to manufacturing support organizations (QA/QC, F&E, PD, Supply Chain, HR, etc.)
• Ensure the coordination and goal alignment of plant production operations with plant support functions.
• Resolve issues between manufacturing and support organizations.
• Assure necessary area infrastructure is maintained to support Plant Operations are maintained in a continuous state of readiness
• Collaborate with cross-functional teams (i.e. Learning and Performance, QA/QC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.
• Interact with site efforts to ensure consistency in policies and practices.

Network:

• Represent plant and / or manufacturing organization on projects, task forces, or various site and network teams.
• Lead major manufacturing related projects across multiple sites.
• Ensure network collaboration and that actions are carried out in the plant.
• Proactively work with other production directors and managers in the network to advance learning and collective performance.

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

Basic Qualifications:

• Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related years OR Bachelor’s degree and 10 years of directly related experience 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

• 10+ years experience in support of commercial drug operations (manufacturing, quality, process development, clinical mfg, engineering)
• 7+ years managing a team (leading and managing operations)
• 3+ years project management (identify goals, manage resources, assign tasks, present progress/milestones, develop cost/benefit analysis and negotiate resolution) 
• Proficient with pharmaceutical product commercialization and life cycle management • Six Sigma Certification (Greenbelt, Blackbelt) 
• 4+ years operations and/or technical experience in the biopharmaceutical industry; depth in one operations area (information systems, manufacturing, quality, process development, engineering, etc.)
• 2+ years experience managing process improvement utilizing Operational Excellence tools and techniques (Catalyst, Lean Manufacturing, etc.) 
• Excellent communication/negotiation skills including executive level communications

As one of the world’s leading biotechnology companies, we focus on discovering and producing medicines and therapies that treat cardiovascular disease, oncology, bone health, neuroscience and nephrology issues, and inflammation.

This is a 20,000 strong, $22bn+ business with a formidable pipeline. We can offer you rare scale and scope. The opportunity to tap into a spirit that fuels success. And the chance to lift your profile further by shaping the future for the biotech industry. While leaving an indelible mark on humanity.   

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.