Cell Therapy Production Specialist
7 days ago
Job Summary:
Innova Solutions is seeking a highly skilled Cell Therapy Specialist to join our team at our state-of-the-art commercial Cell Therapy facility in Maryland. As a Cell Therapy Specialist, you will play a critical role in the manufacture of commercial products, ensuring safe and compliant operations.
Key Responsibilities:
- Perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs)
- Work as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control, and Quality Assurance
- Successfully troubleshoot processing and equipment issues while communicating said issues to management
- Complete required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
- Author and/or revise SOPs that are technically sound, provide clear instructions to align with cGMP requirements, and support efficient operations
- Routinely monitor, clean, prepare, and operate 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
Requirements:
- 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
Benefits:
- Medical & pharmacy coverage
- Dental/vision insurance
- 401(k)
- Health saving account (HSA) and Flexible spending account (FSA)
- Life Insurance
- Pet Insurance
- Short term and Long term Disability
- Accident & Critical illness coverage
- Pre-paid legal & ID theft protection
- Sick time, and other types of paid leaves (as required by law)
- Employee Assistance Program (EAP)
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