Job description

Equivalent Experience

Description:
Cell Therapy Products
Manufacturing Making Cell Therapy (Kite Pharma, GenVivo, Xencor, Amgen)
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 Manufacturing Technician position is responsible for the hands-on manufacturing of clinical cell products in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. They will set up, operate, and maintain various cell therapy production equipment as assigned and thoroughly and accurately document all activities to ensurecompliance with regulatory guidelines. The position will work directly with a team of manufacturing technicians, specialists and scientists in Cell Therapy Manufacturing and Process
Development. Job level and salary will be commensurate with experience.
Performs the hands-on manufacture of cell therapy products, using state-of-theart 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 procedures.
2
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 manner.
Supports Process Development and Manufacturing Sciences, as needed.
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 state.
Cross trains in other areas including Vector Manufacturing, Manufacturing
Sciences, Process Development, QC and QA to perform additional job functions,
as necessary.

Skills:
Clean room, Cell Therapy, batch record review

Top Skills Details:
Clean room,Cell Therapy,batch record review

Additional Skills & Qualifications:
Associates/Bachelor’s (science preferred) degree
6 months to 2 years of relevant or equivalent experience (cGMP manufacturing environment (Adherence Cell Mfg )
Follow Detailed Written Instructions within the lab
Will occasionally require weekend, late evening, and overtime work to support scheduled and unscheduled cell therapy manufacturing operations.

Experience Level:
Intermediate Leve

About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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