Manufacturing Support Associate I - CARsgen Therapeutics Corpora

Position Summary:

Working closely with supervision, Manufacturing Support Assistant contributes to support functions for manufacture of cellular drug therapies within a GMP setting. Operates under current regulations and company policies. Participates in all support operations for the manufacturing CAR-T products including but not limited to cleaning, stocking, and document support.

1. Responsibilities:
   1. Perform scheduled support activities per cGMP.
   2. Write, revise, and review SOPs.
   3. Ensures compliance with documentation and procedures.
   4. Perform and coordinate cleanroom cleaning operations.
   5. Review documentation daily to ensure compliance prior to end of shift.
   6. Perform material coordination activities for manufacturing.
   7. Application of aseptic techniques.
   8. As required, participate in the manufacturing equipment cleaning program and work to assure all critical environments are maintained per qualified methods.
   9. Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.
2. Qualifications:
   1. cGMP experience preferred.
   2. Excellent verbal/written communication skills.
   3. Effectively execute protocols, procedures.
   4. Physical ability to push, pull and lift up to 25 lbs.
   5. Physical ability to stand long periods.
   6. Ability to gown appropriately for cleanroom manufacturing.
   7. Understanding of cGMP documentation and practices.
   8. Basic computer knowledge (emails, word, excel).
   9. Highly ethical and transparent with professional sensitivity and care with confidentiality.
   10. Strong communication, written and verbal and strong organizational and time management skills.
   11. Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.