BioProcess Technician I, Cell Therapy Manufacturing - East Norriton, PA
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 (c
GMPs) 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.
Job Responsibilities
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
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:
Reliable
Adaptable
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.