Title: Cell Therapy Specialist I
Duration: 06-07+ months (possible extension)
Location: Frederick MD
Subject to the Vaccine Mandate/Accommodation
Client: Leading Pharma company
Role is full time 4/10 role but the roles and shifts can change with the needs of the dept. Shift times will be directed by the manager or dept leads.
Example: One team works Sunday – Wednesday and the other team works Wednesday – Saturday. Hours are 7:30am – 6pm. The other team works Sunday – Wednesday and the other team works Wednesday – Saturday. Hours are 5:30pm – 4:00am.
100% on site roles - No flex or WFH available
**Successful candidate must meet the Client Vaccination requirements PRIOR to staring the role
Everyone at this facility is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
We are seeking a highly motivated, Cell Therapy Specialist to join our newly formed Cell Therapy Manufacturing team at our brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
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.
Are you passionate about making an impact on people’s lives? Would you be excited to work for a company leading the way in developing and producing unique, innovative immunotherapies? Do you have a background in cGMP manufacturing? If the answer is yes, we’d like to consider you!
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 revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations
Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms
Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
BA / BS Degree in Sciences Field OR AA Degree with 1+ years of cGMP experience OR High School Degree and 2+ years of cGMP experience
- Record all lab results on laboratory forms
- Complete lab shutdown following the lab SOP
- Produce high quality laboratory testing
- Maintain laboratory inventory and organize laboratory supplies
- Keeping laboratory records and preparing laboratory reports
- Operate lab equipment in accordance with lab internal SOP
- Perform chemical testing on wet samples
- Maintaining laboratory equipment, collecting samples and performing tests
- Perform lab analysis of chemical products
- Maintaining laboratory chemical supplies and equipment
- Assist lab partners with laboratory testing and preparing samples and petri dishes
- Perform lab testing on food products
- Perform tests and procedures using laboratory equipment
- Prepare samples for outside lab testing and compile results
- Gather samples and perform check samples
- Insure that laboratory testing equipment is calibrated
- Performing non-routine lab analysis
- Perform chemical analysis by using various laboratory instruments
- Provide support daily lab testing of incoming raw milk samples
- Troubleshoot laboratory instruments and equipment
- Aseptic Procedures
- Cell Cultures
- Lab Analyses
- Perform Microbiological Analysis
- Prepare Reagent
- Use Aseptic Technique