Specialist Manufacturing (New Product Technology Introduction)

Specialist Manufacturing (New Product Technology Introduction)

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 Specialist Manufacturing (New Product Technology Introduction) in Singapore.

Live

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

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
• 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.

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.