Cell Therapy Specialist
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Apply Now Application ends in 27d 6h 17min
Job Detail
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Offered Salary 0
Job Description
Position Summary:
We are seeking to hire a Cell Therapy Specialist who will participate in the complex manufacturing of modern, cutting-edge cell therapy products in the clean room cGMP compliant environment at our new Frederick facility. Become a part of a company that is pioneering RNA cell therapy and is committed to developing potent yet safer therapies for patients with autoimmune diseases.
Key Responsibilities:
- Execute manufacturing batch records and standard operating procedures (SOPs) for production of clinical material as part of a team in a GMP environment.
- Provide expert consultation on tech transfer activities to the Company’s MSAT department.
- Havea detailed understanding of the manufacturing process and the equipment used for production of clinical material.
- Assess and resolve common problems during cell therapy product
- Comply with cGMP standards and good documentation practices, timely review executed manufacturing documentation, and support internal site audits per compliance
- Undergo advanced training in required SOPs and work instructions for cell therapy manufacturing and train others when necessary.
- Author and revise SOPs as necessary for cell therapy manufacturing
- Document Deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior leadership.
- Ensure that all supplies for manufacturing are replenished and prepared for use in the clean room environment. Assist management with ensuring a steady supply of materials by actively searching for alternative products and suppliers.
Qualifications:
- BS Degree in Life Sciences or Engineering
- Two or more years’ experience in cGMP production of biologics, preferably cell therapy experience.
- 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.
- Ability to apply critical thinking, independent decision-making, high attention to detail, and troubleshooting skills to complex biologics manufacturing, cell culture, and/or cell therapy production issues.
- Sterile gowning and aseptic processing qualifications in previous positions.
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Application ends in 27d 6h 17min