Cell Therapy Specialist
Cell Therapy Specialist
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USD 70000 - 95000
1 Vacancy
Job Description
Cartesian Therapeutics Inc. (Cartesian or the Company) (NASDAQ: RNAC) is a publicly traded clinical-stage biotechnology company pioneering mRNA cell therapies for the treatment of autoimmune diseases. Descartes-08 Cartesians lead candidate is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) currently entering our Phase III AURORA Trial for the treatment of generalized Myasthenia Gravis (gMG). Listen to our December 3 2024 investor call for a discussion of the positive Phase IIb results in gMG. Descartes-08 is also in Phase II development for systemic lupus erythematosus (SLE) with a Phase II pediatric basket trial planned in additional autoimmune indications. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of gMG and Rare Pediatric Disease Designation for the treatment of Juvenile Dermatomyositis. The Companys clinical-stage pipeline also includes Descartes-15 a next-generation autologous anti-BCMA mRNA CAR-T. Cartesians highly integrated approach is a rare find in biotech with discovery cGMP manufacturing and clinical operations all happening under one roof.
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 Companys 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.
Work Environment:
The position requires hands-on work setting up and operating complex equipment in a cleanroom environment. An employee in this position works in an environment in which safety environmental and health concerns demand constant attention. Strict adherence to Cartesians policies rules and regulations is required. While performing the duties of this job the employee handles biological materials in the cleanroom environment. The employee will be required to wear appropriate personal protective equipment including but not limited to eye protection mask coverall gown gloves and shoe covers. Position requires extended periods of standing in a clean room up to 3-6 hours at a time ability to lift 30 lb. and occasional weekend and holiday work.
Salary Notice:
At Cartesian Therapeutics we are committed to transparency and equity in our compensation practices. The salary range for this position is $70000 to $95000 per year. Please note that the final salary will be determined based on several factors including but not limited to years of experience industry experience education and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.
Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race color age religion sex sexual orientation gender identity national origin ancestry disability marital status genetic information military status or any other characteristic protected under applicable law.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
