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.
- 4+ years’ experience with cGMP biologics manufacturing and / or commercial cell therapy operations.
- 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.
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