Senior Manufacturing Technician
Posted on: September 19, 2022
Description: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
- Cell Therapy Products
- Manufacturing Making Cell Therapy (Kite Pharma, GenVivo,
- 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 leaderResponsibilities:
- 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
- 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
- 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
- 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.Additional Skills & Qualifications:
- AA + 3 Years' Experience
- Bachelor's Degree (preferred)
- Open to no degree + several years' experience
- cGMP manufacturing environment (Adherence Cell Mfg
- 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
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
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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