Engineer (Upstream, Cell Culture)

1 week ago

Singapore AMGEN SINGAPORE MANUFACTURING PTE. LTD. Full time

**Engineer I (Upstream, cell culture)**:
**Live**

**What you will do**
- Applies expertise in the successful coordination of multiple, complex, non-routine activities including facility start up, process qualification through to regulatory approval, process performance monitoring, floor support, troubleshooting of unit operations and technology transfer of new processes.
- Must have strong knowledge and understanding of cell culture processes
- Compile and analyze process data using tools such as excel, minitab, JMP, SIMCA
- Verify data in technical reports, spreadsheets and regulatory filings
- Author technical protocols, technical assessments and product impact assessments
- Utilize strong written and verbal communication skills in technical writing and presentations
- Participate/lead in teams and collaborate cross-functionally with representatives from other functions and sites to transfer and support drug substance manufacturing processes
- Organize and conduct meetings. Actively creates, generates, and presents data/conclusions at internal and cross functional meetings
- Be part of digitation of process tech transfer

**Win**

**What we expect of you**

**Qualifications**:

- Master’s degree OR
- Bachelor’s degree and 2 years of directly related experience OR
- Associate’s degree and/or 6 years of directly related experience OR
- High school diploma / GED and 8 years of directly related experience
- Experience working with commercial manufacture of biologics using single use technology
- Experience related to upstream process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities.
- Possess basic understanding of regulatory and cGMP requirements
- Able to elevate relevant issues to project lead and line management
- Independently motivated but also work well in team environment
- Excellent written and verbal communication

**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

**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.

**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.

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