Cell Therapy Specialist I
United States - Maryland - FrederickRegularОписание вакансии
We are seeking a highly motivated Cell Therapy Specialist I to join our Cell Therapy Manufacturing team at a state-of-the-art commercial cell therapy facility in Frederick, Maryland. This role is responsible for performing and verifying tasks associated with the manufacture of commercial and clinical cell therapy products in accordance with batch records and standard operating procedures. The Cell Therapy Specialist I works as part of a cross-functional team to execute GMP manufacturing runs in close collaboration with Materials Management, Quality Control, and Quality Assurance.
Key Responsibilities
Perform and verify manufacturing activities for commercial and clinical cell therapy products in compliance with approved batch records and SOPs
Troubleshoot processing and equipment issues and communicate findings to management in a timely manner
Operate, monitor, clean, and prepare automated cell processing equipment in Grade B and C cleanroom environments
Maintain strict adherence to cGMP requirements, safety standards, and gowning and PPE requirements for classified manufacturing areas
Complete all required training assignments to maintain technical proficiency and regulatory compliance
Identify opportunities to improve manufacturing efficiency and compliance
Support investigations, deviations, and change control activities as needed
Wear a respirator when working with hazardous disinfectants, as required
Basic Qualifications
Associate degree with a minimum of 1 year of relevant experience, or
High School Diploma or GED with a minimum of 2 years of relevant experience
Preferred Qualifications
Bachelor’s Degree
Prior experience working in a GMP-regulated manufacturing environment or aseptic processing environment
Experience supporting investigations, deviations, and change control processes
Physical and Work Environment Requirements
Availability to work holidays based on operational requirements .
Ability to work in a cleanroom manufacturing environment
Ability to wear required PPE, including respirators, for extended periods
Ability to perform tasks that may require standing, lifting, and repetitive motions