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Senior Manufacturing Technician

Company: Actalent
Location: Arcadia
Posted on: September 15, 2022

Job Description:

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 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 procedures.

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.

Trains and leads other Technician I on all processes and equipment functionality.

Responsible for assisting with startup activities in area of responsibility.

Assists in commissioning & qualification of production equipment.

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 procedures.

Effectively demonstrates understanding of cGMPs & applies to specific responsibilities.

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.

Skills:

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 operations.

Experience Level:

Expert Level

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.

Keywords: Actalent, Arcadia , Senior Manufacturing Technician, Professions , Arcadia, California

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