Location: all cities,NC, USA
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.