Specialist Manufacturing (New Product Technology Introduction)

at  Amgen

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

• Work with Senior Manager to develop and advance digitalization roadmap and metrics/dashboard for manufacturing support team
• 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