GMP manufacturing technician

1 month ago


Frederick, United States Intelliswift Software Full time

Title: Cell Therapy Specialist I

Location: Frederick, MD

Duration: 12 Plus Months + will extended


6:00 am to 4:30 pm (Day Shift), Sun-Wed and Wed-Sat

3:00 pm to 1:30 am (Swing Shift), Sun-Wed and Wed-Sat


DDMM::05/01


Job Description

The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.


Responsibilities of the Cell Therapy Specialist include:


Successfully troubleshoots processing and equipment issues while communicating said issues to management

Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements

Authors and/or revise SOPs that are technically sound, provides clear instructions to align with cGMP requirements and support efficient operations

Routinely monitors, cleans, prepares, and operates sophisticated automated cell processing, cell expansion, and filling equipment in Grade B/C clean rooms

all required PPE and gowning for classified GMP manufacturing areas is provided by the company.

Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls


Basic Requirements:'

BA / BS Degree in Sciences Field

AA Degree with 1+ years of cGMP experience

High School Degree and 2+ years of cGMP experience



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