Manufacturing Manager (Single Use)

Manufacturing Manager (Single Use)

Singapore

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 Manufacturing Manager (Single Use) in Singapore.

Live

What you will do

This role is within the manufacturing organization of Amgen Singapore Manufacturing. The Manufacturing Manager (Single Use) provides technical support to the manufacturing execution team. We offer a broad exposure to all key aspect of GMP manufacturing as well as tactical and strategic teamwork within the extended manufacturing network.

• Applying engineering principles to recommend, design and implement new single use systems/modifications

• Able to provide technical recommendations for single use requirements during plant fits and site assessments for new product introduction 
• Staying current with new single use systems/technologies trend and responsible for introduction of new systems/technologies
• Working closely with multiple disciplines, including manufacturing, facility & engineering, quality assurance and validation to implement operational improvements
• Ensuring optimal and cost-effective performance and reliability for process systems
  • Use critical thinking skills and operational knowledge to generate productivity and operational efficiency initiatives
  • Use critical thinking skills and technical knowledge to advance the reliability for single use systems
  • Pro-actively seek technological, automation or digitalization advancement, improve plant productivity and other business workflow
• Providing technical support to commercial manufacturing as needed
• Serves as expert resource to lead and drive science based, data-driven troubleshooting and resolution of single use issues of high complexity
• Own, lead and drive root cause analysis of major investigations (related to single use systems) including the development and implementation of corrective and preventive actions
• Initiate and manage change controls (related to single use systems) of moderate to complex scope including but not limited to continuous improvement and productivity initiatives.
• Developing, organizing, analyzing and presenting results for operational issues and engineering projects of moderate scope and complexity. Able to influence audience to make decisions, provide constructive feedback and/or resolutions
• Represent ASM in network meetings/projects effectively.
  • Able to communicate clearly ASM requirements/inputs for network projects
  • Support technical evaluation and alignment with the network
  • Actively share ASM best practices and adopt best practices from the network (when applicable)
• Responsible for providing regular updates on single use systems performance to site leadership team during management reviews independently
• Able to propose and lead improvements to workflow processes related to single use (e.g. SICAR/EN, bag decontamination, defect analysis) affecting multiple Amgen sites
• Serves as subject matter expert during regulatory inspections
• Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
• Responsible for management and oversight of senior/manufacturing associates to provide technical support for single use systems
• Coach, mentor and/or cross train staff within core technical areas.  Drive forward employee engagement activities to differentiate site/company as a great place to work

Win

What we expect of you

Qualifications

Win

What we expect of you

• Doctorate degree OR
• Master’s degree in Engineering/Science & 2 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s degree in Engineering/Science & 4 years of experience in a pharmaceutical company or GMP environment OR
• Diploma in Engineering/Science & 8 years of experience in a pharmaceutical company or GMP environment

• Extensive knowledge of Mammalian Cell Culture, Protein Purification, Single Use Systems
• Experience with Technology Transfer, Process Design, and Commissioning
• Experience with validation and change control methodology
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
• Position requires excellent written and verbal communication skills and the ability to work with minimum direction
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
• Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
• Experience that includes the management of complex projects, tasks or processes, or management of functional or cross-functional teams
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, quality engineering, quality control, and quality assurance
• Experience that has provided the candidate with a detailed understanding of the regulatory and compliance environment, the GMP processes and the business processes associated with typical biotechnology / pharmaceutical manufacturing operations

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.