What are the responsibilities and job description for the Cell Therapy Manufacturing Specialist position at Unicon Pharma Inc?
About the Role
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
- 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
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
Required Skills
cGMP manufacturing experience