About the job
BioProcess Technician I, Cell Therapy Manufacturing
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General Company Description
My client is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.
Position Summary & Role
The Technician I, Cell Therapy Manufacturing position is responsible for the hands-on clinical manufacturing of 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 and report to the Bioprocess and Cell Therapy Supervisor.
- Participates in the hands-on manufacture of cell therapy products, using state-of-the-art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer).
- 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.
Preferred Experience, Education & Qualifications
- Associates/Bachelor’s (science preferred) degree with 0-2 years of relevant or equivalent experience.
- Excellent oral and written communication skills.
- Strong organization skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently.
- Good attention to detail and ability to follow written procedures.
- Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines.
Other Ideal Personal Characteristics:
· Willingness to learn
· Must be able to work in setting with Biohazards and various Chemicals.
· Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE).
· Must be able to work in environment with variable noise levels.
· Ability to stand, sit, and walk for long periods of time.
Ability to lift, push and pull 40 lbs. routinely.
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