CARsgen Therapeutics is seeking a highly motivated professional with Cell Therapy and/or Cell Culture manufacturing experience. This role will support production and facility start-up initiatives for our clinical stage CAR-T Cell therapy products at our RTP, North Carolina facility.
Responsibilities:
Daily manufacturing of cell therapy products in a Grade A (Biological Safety Cabinet)/Grade B clean room environment, including open manipulations and use of cell processing equipment.
Act as subject matter expert (SME) for related manufacturing operations and equipment and be able to provide on the floor support.
Author and revise Standard Operating Procedures (SOPs), manufacturing batch records, and other related documents in accordance with GMP requirements and regulations.
Initiate and manage Deviation, CAPA, Change Control, and Effectiveness verification reports and ensure all action items are completed in a timely manner.
Coach and train team members ensuring proper Aseptic Technique, clean room behavior, and compliance with written procedures
Lead process improvement initiatives in collaboration with Manufacturing Science and Technology (MSAT) and quality departments.
Maintain a high level of accountability and integrity
Support Regulatory Audit activities as a manufacturing department SME and representative and ensure audit readiness of respective area
Qualifications:
Bachelor's degree in relevant science or engineering discipline.
Experience with CAR-T manufacturing, cell culture, cryopreservation, purification, filling, visual inspection, and aseptic processing highly preferred.
Ability to work independently and stay on task in a fast-paced environment without direct supervision
Knowledge of cGMP/FDA regulations, quality standards, documentation and practices.
Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments with appropriate PPE and occasional lifting of heavy materials.
Must have experience in drafting and reviewing technical documents with strong technical writing skill.
Expertise in aseptic/sterile techniques and familiarity with cell culture equipment.
Strong critical thinking, troubleshooting, and problem-solving abilities.
Self-motivated with a willingness to undertake temporary responsibilities beyond the initial job description.