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 L
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
Skills: 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).