Cell Therapy Specialist
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Job Detail
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Job Description
Job Description
We are seeking a Cell Therapy Specialist to join our team. In this role, you will execute manufacturing batch records and standard operating procedures (SOPs) for the production of clinical material in a GMP environment. You will provide expert consultation on tech transfer activities and have a deep understanding of the manufacturing process and the equipment used for production. This position involves resolving common problems during cell therapy product manufacturing, ensuring compliance with cGMP standards, and supporting internal site audits. You will also undergo advanced training and train others in cell therapy manufacturing processes, author and revise SOPs, and document deviations and CAPAs.
Responsibilities
- Execute manufacturing batch records and SOPs for production of clinical material in a GMP environment.
- Provide expert consultation on tech transfer activities.
- Understand the manufacturing process and equipment used for production of clinical material.
- Assess and resolve common problems during cell therapy product manufacturing.
- Comply with cGMP standards and good documentation practices.
- Timely review of executed manufacturing documentation.
- Support internal site audits per compliance.
- Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing.
- Train others in cell therapy manufacturing processes.
- Author and revise SOPs as necessary for cell therapy manufacturing.
- Document deviations and CAPAs, investigate and resolve problems, identify root causes, and propose process improvements.
- Ensure that all supplies for manufacturing are replenished and prepared for use in the cleanroom environment.
- Assist management with ensuring a steady supply of materials by searching for alternative products and suppliers.
Essential Skills
- Significant knowledge in the biologics manufacturing process, cell culture, and/or cell therapy production.
- Excellent documentation skills, including following and completing documentation associated with cGMP manufacturing.
- Critical thinking and independent decision-making skills.
- High attention to detail and troubleshooting skills.
- Sterile gowning and aseptic processing qualifications.
Additional Skills & Qualifications
- BS Degree in Life Sciences or Engineering.
- 1+ years’ experience in cGMP production of biologics, preferably cell therapy experience.
Work Environment
This position requires hands-on work setting up and operating complex equipment in a cleanroom environment. Safety, environmental, and health concerns demand constant attention. Strict adherence to company policies, rules, and regulations is required. The employee will handle biological materials in the cleanroom environment and will be required to wear appropriate personal protective equipment, including eye protection, mask, coverall gown, gloves, and shoe covers. The position requires extended periods of standing in the cleanroom, up to 3-6 hours at a time, the ability to lift 30 lb., and occasional weekend and holiday work.