General Description:
The Cell Culture Manufacturing Senior Technician position will directly enable the initial start-up phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations.
- Hands-On cGMP Operations: Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and compliantly. Essential functions of the job include but not limited to:
- Follow cGMP procedures to support manufacturing execution and automated recipes
- Clean-In-Place (CIP) & Steam-In-Place (SIP)
- Media preparation & transfers / filtration
- Cell culture sampling, monitoring & transferring
- Harvest operations
- Equipment & process troubleshooting
- Deviation identification, reporting and closure
- cGMP procedure development and optimization
- Cleaning and garbage discharge
- 6S operation
- Equipment validation (bioreactor IOQ and PQ study, but not limited to the other cell culture validation activity).
Experience Required
- At least 3-5 years working in cell culture area in Biopharm industry.
- Familiar with single use bioreactor, such as Wave bioreactor, Sartorius or Cytiva bioreactor 200-2000L
- Familiar with inoculation aseptic technique
- Familiar with stainless steel vessel operation with DCS control (Medium Preparation, CIP/SIP)
- Familiar with Part washer or autoclave operation
Education:
- High school education or GED required.
Or
AS/BS/BA in science related field, biopharmaceutical or equivalent technical experience preferred.
