Lead Manufacturing Associate - FLEX shft

Lead Manufacturing Associate - FLEX shift

Company Name: Cartesian Therapeutics

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, Cartesian's 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). 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 Company's clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. Cartesian's highly integrated approach is a rare find in biotech, with discovery, cGMP manufacturing, and clinical operations all happening under one roof.

Position Summary

Reporting to the Manufacturing Manager, the Lead Manufacturing Associate will participate in the manufacturing of modern cutting-edge cell therapy products in the clean room cGMP compliant environment. The successful candidate will supervise and lead a team of cell therapy specialists, execute batch records, follow SOPs and participate in the experiments in the Company's process development laboratory; they will document, analyze, and interpret results; draft in technical reports; and perform the company manufacturing operations per cGMP standards. This is a FLEX shift role, and the ability and willingness to work Wednesday through Sunday on a regular basis is required.

Key Responsibilities

• Manufacture the clinical product following the batch records and standard operating procedures (SOPs) as part of a team in a GMP environment.
• Manage and lead a team of 2-4 Cell Therapy Specialists to ensure high-quality products are manufactured on schedule.
• Have a detailed understanding of the manufacturing process and the equipment used for production. Be able to troubleshoot common problems during cell therapy product manufacturing.
• Comply with cGMP standards and good documentation practices, timely review executed manufacturing documentation, support internal site audits per compliance standards.
• Be fully trained in required SOPs for cell therapy manufacturing and train others when necessary.
• Author and revise SOPs as necessary for cell therapy manufacturing products.
• Document Deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior management.
• Ensure that all manufacturing supplies 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.
• Engage in continuous improvement to improve operational efficiency.

Qualifications

• Bachelor's degree (or higher) in a related field with 4-5 years' experience in biologics drug substance process development and cGMP manufacturing; cell therapy experience is required.
• Experience managing a manufacturing team in a cGMP environment.
• Strong technical expertise in Biologics upstream processes, including aseptic techniques, cell culture, and bioreactor operation.
• A strong sense of urgency with regards to work duty and timeline.
• Ability to adapt to rapidly changing schedule.
• Ability to work in a highly collaborative and virtual environment leveraging external collaborations to accomplish individual and team goals.
• Detail-oriented with excellent verbal and written communication skills.

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 Cartesian's 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 $88,000 to $112,000 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.

Equal Opportunity Employer

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.