Sr. Specialist, Cell Therapy Manufacturing - CARsgen Therapeutics : Job Details

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.