Senior Manufacturing Technician
Posted on: September 15, 2022
Cell Therapy Products
Manufacturing Making Cell Therapy (Kite Pharma, GenVivo, Xencor,
Office Environment; A lot of administrative duties
Policy Writing, Procedure Writing, Technical Writing
Writing Batch Records and SOP's
Will do more administrative 3-5 months, once clean rooms get going
then they would move to the MFG floor and clean rooms
Would be a floor leader
The Senior Manufacturing Technician, Cell Therapy position is
responsible for the hands-on manufacturing of clinical cell therapy
product according to current Good Manufacturing Practices (cGMPs)
and procedures. The position will work directly with a team of
manufacturing technicians, specialists and scientists in Cell
Therapy Manufacturing and Process Development.
Participates in the hands-on manufacture of cell therapy products,
using state-of-the-art cell manufacturing technologies (i.e.,
CliniMACS Prodigy, Xuri Bioreactor, M1 Fill and Finish System,
etc.), media preparation, cell culture maintenance, sampling and
cell counting (i.e., NC200 and CellDrop).
Follows and executes batch records and standard operation
Performs aseptic and closed manipulations within Biosafety Cabinet
and Grade B, C and D Cleanrooms.
Performs manufacturing process steps in accordance with cGMP,
procedures and relevant regulations.
Performs delegated work assignments in a timely and complete
Supports Process Development and Manufacturing Sciences, as
Authors and maintains controlled documents including but not
limited to SOPs, forms and batch records.
Assists with deviation investigations and implementing CAPAs.
Assists with qualification and validation activities including
equipment qualification, gown qualification, aseptic process
validation and process qualification/validation.
Maintains manufacturing facility in a 5S and inspection-ready
Cross trains in other areas including Vector Manufacturing,
Manufacturing Sciences, Process Development, QC and QA to perform
additional job functions, as necessary.
Trains and leads other Technician I on all processes and equipment
Responsible for assisting with startup activities in area of
Assists in commissioning & qualification of production
Assists in the review & creation of operation documents by
providing input to technical composition of documents.
Operates on the manufacturing floor in accordance with cGMP's and
standard operating procedures.
Prepares equipment for manufacturing operations and monitors
equipment to ensure process specifications are met.
Uses and maintains bench top equipment in accordance with relevant
Effectively demonstrates understanding of cGMPs & applies to
Follows accurate oral & written procedures when operating
production equipment & performing processing steps.
Maintains orderliness of process area.
Practices safe work habits and adheres to Resilience's safety
procedures and guidelines.
Assists in training of new and junior staff.
Utilizes manufacturing knowledge to improve process operations and
affect positive change.
Escalates issues related to product and safety to senior staff.
Clean room, Cell Therapy, batch record review
Top Skills Details:
Clean room,Cell Therapy,batch record review
Additional Skills & Qualifications:
AA + 3 Years' Experience
Bachelor's Degree (preferred)
Open to no degree + several years' experience
cGMP manufacturing environment
Follow Detailed Written Instructions within the lab
Someone who can use the years of experience to problem solve and
teach others best practice
Will occasionally require weekend, late evening, and overtime work
to support scheduled and unscheduled cell therapy manufacturing
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gender identity, genetic information or any characteristic
protected by law.
Keywords: Actalent, Arcadia , Senior Manufacturing Technician, Professions , Arcadia, California
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