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.

1. 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:
2. Follow cGMP procedures to support manufacturing execution and automated recipes
3. Clean-In-Place (CIP) & Steam-In-Place (SIP)
4. Media preparation & transfers / filtration
5. Cell culture sampling, monitoring & transferring
6. Harvest operations
7. Equipment & process troubleshooting
8. Deviation identification, reporting and closure
9. cGMP procedure development and optimization
10. Cleaning and garbage discharge
11. 6S operation
12. 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 BioPharma 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.