What are the responsibilities and job description for the Cell Therapy Specialist – GMP Manufacturing | Commercial Cell Therapy Production position at Cube Hub Inc.?
Description:
4-6 months contract ; May extend
IMPORTANT: For the first 8-10 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing Onboarding Technical Training. After the training is successfully completed, the contractor is deployed onto the shift as needed by the department leadership. Once deployed to shift, employees will be considered "essential" and will work their respective shifts during company holidays/shutdowns.
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.
6:00 am to 4:30 pm (Day Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
3:00 pm to 1:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
5:00 pm to 3:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
Basic Qualifications:
• Bachelor’s Degree in Life Sciences Field
• Associates Degree in Life Sciences Field with 1 years of biotech experience or
• High School Diploma with 2 years of cGMP experience
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 (include but are not limited to):
To be considered for this role, you must meet the following basic criteria:
• 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. All required PPE and gowning for classified GMP manufacturing areas are provided by the company.
• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
• Ability to wear a respirator during use of certain cleaning chemicals