Specialist Manufacturing

**Specialist Manufacturing**

**Amgen Singapore Manufacturing**

**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 I** in **Amgen Singapore Manufacturing**.

**Live**

**What you will do**

Amgen Singapore Manufacturing is responsible for drug substance manufacturing and release of Amgen’s commercial product using innovative manufacturing platforms and technologies. Reporting to the Senior Manager Manufacturing, we are seeking to appoint a well-qualified and experienced individual to assume the role of Manufacturing Specialist. With mínimal direction or supervision, the Manufacturing Specialist has three main core responsibilities: contamination control, inspection readiness and risk management. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide manufacturing network.

**Responsibilities**:
**Contamination Control**
- Contamination Control Lead for ASM1 Manufacturing
- Lead contamination program and strategies in ASM1 manufacturing.
- Represent ASM1 Manufacturing in the Contamination Control Network (CCN) and actively collaborate with the network
- Responsible for metrics review and reporting pertaining to the contamination control program
- Maintain clean room procedures, gowning practices, contamination response and oversee the environmental monitoring program.
- Perform routine monitoring, identify weak signals and provide prompt follow ups to mitigate potential contamination risks.
- Ensure adherence and alignment to regulatory guidelines and standards, and network requirements.
- Lead and drive root cause analysis investigations arising from contamination events/deviations including the development and implementation of corrective and preventive actions with mínimal supervision
- Identify and drive opportunities to optimize ASM1 Manufacturing’s contamination control program and its effectiveness
- Manage EM Sampling team to ensure adherence to EM program requirements
- Support gowning training (where applicable) as qualified trainer

**Inspection Readiness**
- Serve as Pre-Approval Inspection (PAI) Lead for ASM1 Manufacturing
- Work closely with compliance and cross-functional teams to ensure prompt follow-ups on inspection requests
- Develop and build up ASM1 Manufacturing’s technical expertise and capabilities to ensure site inspection readiness (e.g., pressure tests)
- Triage lead for ASM1 Manufacturing during regulatory inspections / audits
- Establish defined timelines and provide follow ups on audit findings, near misses and lessons learnt
- Working knowledge of key systems including change controls, deviations / investigations, corrective / preventive actions
- Support ASM2 Manufacturing to ensure ASM2 Manufacturing inspection readiness (areas related to change controls and deviations)

**Risk Management**
- Trained SME on Failure Mode and Effective Analysis (FMEA) and maintain risk assessments pertaining to ASM Manufacturing
- Serve as facilitator in FMEA risk assessment discussions and engage key stakeholders appropriately to manage risk assessment revisions / updates ensuring continued compliance
- Lead, manage and implement change controls independently where applicable.

**Win**

**What we expect of you**

**Qualifications**
- Doctorate degree OR
- Master’s degree and 2 years of directly related experience OR
- Bachelor’s degree and 4 years of directly related experience OR
- Diploma and 8 years of directly related experience
- Technical knowledge of biopharmaceutical upstream, downstream processing and single use system
- Understanding of regulatory guidelines and requirements pertaining to contamination control in biologics manufacturing
- Strong communication skills - ability to communicate effectively with the cross-functional stakeholders and network partners
- Ability to work under mínimal guidance and drive continuous improvement initiatives and lead highly complex investigations
- Strong analytical and critical thinking capability - ability to respond to changes, gather required data, evaluate options, and communicate analysis recommendations to facilitate decision making
- Ability to coach, train and develop Manufacturing Associates

**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