Amgen Sr Mgr Process Development in Singapore, Singapore
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 will provide scientific and technical leadership within the Process Development group at Amgen’s Next Generation Biologics Manufacturing Facility in Singapore. This is one of the most advanced biotech manufacturing facilities in the world: employing the latest technologies for single use processing, connected processing, and real-time process analytical technologies.
1) The senior manager will lead a group of process scientists with cell culture and purification background. The team will optimize cell culture processes for improved productivity as part of the life cycle management of Amgen’s commercial portfolio.
2) As part of this leadership role, he/she will develop strong teams and support staff in career development. The scope of work and responsibility span commercial process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, the position will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.
3) The candidate should have experience:
Leading teams with direct reports in a Process Development group
Managing key projects or business processes across functions
Integrating trends, data and information into plans, deliverables and recommendations
Employing project management techniques
Applying advanced technical principles, theories and concepts for troubleshooting
4) The candidate will work in the Process Development Department at Amgen’s Next Generation Manufacturing Facility to:
Lead a team of scientist and engineers that and perform laboratory activities and provide commercial support
Lead investigations, complete impact assessments, participate in regulatory inspections/audits, provide regulatory responses and other technical support to process transfers and ongoing manufacturing as required
Act as Drug Substance Team Leader for one of the therapeutic proteins produced in Singapore. This is a portion of the position and is a global role that interacts with other experts in the areas of Regulatory Affairs, Quality, Business Operations, Supply Chain, and Attributes Sciences.
Make budget recommendation and oversee expenditures
Identifies relevant external competitive knowledge
Initiates productive collaborations outside of the department or company
Introduces new or advanced technologies and/or concepts
May contribute to scientific journal articles or complex technical documents as lead
Doctorate degree in Engineering, Science or related technological field and 2 years of directly related experience OR
Master’s degree in Engineering, Science or related technological field and 6 years of directly related experience OR
Bachelor’s degree in Engineering, Science or related technological field and/or 8 years of directly related experience
Advanced degree in Science or Engineering
Experience in mammalian cell culture sciences in biopharmaceutical manufacturing.
Extensive experience in development and/or support of commercial manufacturing processes, including process scale-up
Experience resolving technical issues and knowledge of requirements to produce therapeutic proteins through mammalian cell culture is essential
Ability to motivate, lead and/or supervise the activities of others.
Demonstrate skills in independently determining and developing scientific analysis and solutions.
Track record of innovation and implementation of new technologies
Demonstrate strong laboratory and project management skills.
Experience in process validation/process performance qualification
Experience in authoring BLA sections and interaction with regulatory agencies
Experience developing staff to reach their full potential
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.