Specialist Manufacturing

Amgen Inc. (IR); Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Amgen Singapore is seeking a Manufacturing Specialist to lead New Product Introduction (NPI) readiness, manage cross-functional NPI activities, and drive site productivity improvements within a next-generation biologics facility. The role requires coordinating manufacturing documents, budgets, and schedules with Engineering, Quality, Supply Chain and Automation teams.

You will also lead cross-functional projects, develop business cases for new equipment, and ensure adherence to regulatory

Qualifications

• PhD or MSc in Engineering/Science with 2+ years in pharma or GMP environment.
• Bachelor's degree in Engineering/Science with 4+ years in pharma or GMP environment.
• Diploma in Engineering/Science with 8+ years in pharma or GMP environment.

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.

Skills

Team leadership

Communication

Analytical thinking

Project management

Education

Doctorate or MSc in Eng/Science

Bachelor's in Eng/Science

Diploma in Eng/Science

Tools

MS Project

MS Excel

SAP

PI-Vision

Smartsheet

Spotfire

Job description

Career Category Manufacturing Job Description

Join Amgen's 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 world's 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 Master's degree in Engineering/Science and 2 years of experience in pharmaceutical company or GMP environment
• Bachelor's degree in Engineering/Science and 4 years of experience in pharmaceutical company or GMP environment
• 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, we'll support your growth both professionally and personally.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen