Specialist Manufacturing
Job Summary
Join Amgens Mission to Serve Patients
At Amgen our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.
Amgen fights the worlds toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer fuller lives.
If you are energized by collaboration continuous learning and meaningful work we invite you to join our team and help make an impact.
Specialist Manufacturing I
What you will do
Amgen has built a next generation biologics facility in Singapore as part of its global expansion strategy. We are seeking to appoint a well-qualified and experienced individual to assume the role of Manufacturing Specialist. With minimal direction or supervision the Manufacturing Specialist will be the primary contact representing manufacturing as part of New Product/Technology Introduction. This role will also offer the opportunity to manage manufacturing related projects drive productivity/continuous improvement initiatives manage the site project prioritization process as well as engaging management to develop manage and ensure adherence to department financial budgets.
Responsibilities
New Product Introduction (NPI)
Lead manufacturing to support site/facility fit assessments for new product
Represent ASM in Digital Tech Transfer (DTT) initiatives
Identify and drive improvements in NPI workflow
Serve as NPI lead and responsible for cross-functional NPI readiness (Manufacturing/Supply chain/Engineering/Automation//EHS/Validation) during New Product Introduction
Develop and manage schedule for NPI/operational readiness. Ensure adherence to committed schedule/budget
Responsible for readiness of manufacturing documents/systems to support new product introduction including but not limited to SOP SUD batch records BOM
Manage and serve as Subject Matter Expert (SME) during regulatory inspections for NPI related change controls deviations/investigations corrective/preventative actions
New Equipment/Technology Introduction
Project lead for site projects impacting manufacturing (including change control ownership)
Lead cross-function and complex projects using project management skills
Develop project deliverables schedules and ensure adherence by cross-functional team
Actively engage networks other Amgen sites and technology providers to identify potential advancement in technologies
Support development of business cases/feasibility assessments for new equipment/technology introduction
Provide user inputs during development of URS commissioning qualification protocols
Develop and lead wet tests when required during new process equipment or product introduction
Productivity/Continuous Improvements
Responsible for manufacturing productivity targets and track timely completion of initiatives to achieve productivity savings
Support continuous improvement/productivity initiatives when needed (including change control ownership for improvement projects)
Support manufacturing for EIO/OIA awards submissions
Identify and/or implement transformational changes to current business processes/systems specifically related to rapid NPI and high run rate production (run rate assessment)
Work with cross functional teams to value stream identify bottlenecks and eliminate waste
Digitalization
Drive digital transformation initiatives within manufacturing by developing and implementing digital tools dashboards and workflow solutions that enhance project visibility standardize processes and improve cross-functional collaboration and execution efficiency
Seek technological automation or digitalization advancement to improve business workflows
Finance
Responsible for manufacturing budget development management and review
Support manufacturing management on requests related to finance
Support purchase requisition transactions in SAP
What we expect of you
Doctorate Degree
Masters degree in Engineering/Science and 2 years of experience in pharmaceutical company or GMP environment OR
Bachelors degree in Engineering/Science and 4 years of experience in pharmaceutical company or GMP environment OR
Diploma in Engineering/Science and 8 years of experience in pharmaceutical company OR GMP environment
Demonstrated ability to lead/work well with teams open to changes and new ideas
Strong communication skills - ability to lead meetings and communicate effectively
Strong analytical and critical thinking capability ability to respond to changes gather required data evaluate options and communicate analysis recommendations to facilitate decision making
Attention to details strong organizational/project management skills and error-proofing habits
Knowledge of facility and manufacturing processes
Knowledge of tools and systems (MS Project MS Excel SAP PI-Vision Smartsheet Spotfire)
Ability to create and standardize business/work processes
Ability to coach train and develop manufacturing associates
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.
What you can expect of us
As we work to develop medicines for patients we also invest in our people. Through competitive benefits development opportunities and a collaborative culture well support your growth both professionally and personally.
Apply now and help transform the lives of patients while transforming your career.
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 and live the Amgen values as we continue advancing science to serve patients. Together we compete in the fight against serious disease.
Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
.Required Experience:
IC
About Company
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 ... View more