Specialist Manufacturing
5 days ago
**Role Description**
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.
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 mínimal direction or supervision, the Manufacturing Specialist will be the primary contact and technical resource representing manufacturing as part of a New Technology Introduction. This role will offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved single use resiliency for the site.
**Responsibilities**
- Lead strategic initiatives and establish framework for single use resiliency plan for Amgen Singapore Manufacturing
- Lead site initiative to drive implementation of new generation of single use freeze thaw bags by working closely with Amgen Drug Product Team
- Serve as site contact to manage the implementation and development of standardized electronic batch records templates
- Work with cross functional teams to value stream new technology introductions (NTI); be able to identify and articulate bottlenecks and eliminate waste
- Manage floor continuous improvement efforts for Amgen Singapore Manufacturing. Inspire and inculcate a continuous improvement culture on the production floor.
- Coach floor staff on problem solving methodology and work with cross functional team on problem solving and implement/support continuous improvement opportunities
- Identify transformational changes to current business processes / systems, specifically related to rapid NTI and high run rate production (e.g., through use of product life cycle management platforms)
- Experienced technical lead for the introduction of advanced processes and equipment technologies including single use systems (SUS) into the plant.
- Manage change controls, corrective actions and preventative actions associated with the new product introduction
**Basic Qualifications**
- Doctorate degreein Engineering, Math, or Science OR
- Master’s degreein Engineering, Math, or Science and 2 years of directly related experience OR
- Bachelor’s degreein Engineering, Math, or Science and 4 years of directly related experience OR
- Diplomain Engineering, Math, or Science and 8 years of directly related experience AND
- Have a proven track record in leading critical single use mitigation initiatives to address global supply concern of single use material
- Have a proven track record in leading technical transfer cross functional team to enable complex product life cycle management activities in a commercial plant.
- Strong quality background focusing on supply chain and quality deviations
**Preferred Qualifications**
- Bachelor’s degree or above in Engineering, Math, or Science and demonstration of strong analytical competency
- Demonstrated ability to work well with teams, open to change and new ideas
- Strong communication skills - ability to lead meetings, communicate effectively
- Strong analytical and critical thinking capability - able to respond to changes, gather required data, evaluate options, and communicate analysis recommendations to facilitate decision making
- Attention to detail, strong organizational skills and error-proofing habits
- Knowledge of facility and manufacturing process
- Knowledge of tools and systems (MS Project, SAP, PI, Excel)
- Ability to create business processes and standardize work
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