Engineer I (Upstream, cell culture)
Live
What you will do
The successful candidate will apply process engineering knowledge to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:
- 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 apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
· 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
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.
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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.
