Biologics Manufacturing Specialist

20 hours ago


Frederick, Maryland, United States Cartesian Therapeutics Full time
Company Overview:
At Cartesian Therapeutics, we are pioneering RNA cell therapy to bring new treatment options to patients with autoimmune diseases. Our team is committed to developing potent yet safer therapies for those in need.

Job Description:
The Cell Therapy Specialist will play a crucial role in the complex manufacturing of modern cell therapy products in our clean room cGMP compliant environment. This position requires hands-on work setting up and operating complex equipment, ensuring strict adherence to company policies, rules, and regulations. The ideal candidate will have experience in cGMP production of biologics, preferably cell therapy experience, and excellent documentation skills.

Responsibilities:
  • Execute manufacturing batch records and standard operating procedures (SOPs) for production of clinical material.
  • Provide expert consultation on tech transfer activities to the Company's MSAT department.
  • Have a detailed understanding of the manufacturing process and the equipment used for production of clinical material.
  • Assess and resolve common problems during cell therapy product production.
  • 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.

Salary:$70,000 - $95,000 per year. The final salary will be determined based on several factors, including 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.

Benefits:
  • A competitive salary range.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for professional growth and development.
  • A dynamic and inclusive work environment.


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