Job Title:

GMP Manufacturing Technician Location:

Tarzana, CA Duration:

06+ Months (Contract/Temp with the possibility of extension)

Shift:

1st

Shift Schedule:

Monday-Friday, 8-hour shifts; schedule may transition to a 4x10 schedule (Sunday-Wednesday or Wednesday-Saturday)

Pay Range:

$23.00/hour We are seeking an experienced GMP Manufacturing Technician to support the manufacturing of investigational CAR-T, TCR-T, and allogeneic cell therapy products in a GMP environment. The ideal candidate will have hands-on experience with cell therapy manufacturing, aseptic processing, cleanroom operations, GMP documentation, and cell-processing equipment. This position will support manufacturing readiness, technology transfer, production activities, and compliance with cGMP requirements.

Key Responsibilities:

Perform manufacturing activities in a GMP/cleanroom environment while following safety, quality, and cGMP requirements. Support manufacturing readiness activities, including equipment installation/qualification, facility qualification, and technology transfer. Set up manufacturing areas and operate automated cell-processing equipment. Perform aseptic operations and follow established cleaning and gowning procedures. Maintain cleanroom inventory of materials and supplies required for manufacturing. Ensure materials and equipment are properly identified and available for scheduled manufacturing activities. Assist with developing and maintaining SOPs and manufacturing documentation. Support Process Development (PD) and Manufacturing Sciences & Technology (MSAT) activities. Support production operations in compliance with GMP and applicable regulatory requirements. Assist with deviation support and manufacturing investigations. Provide verbal and written status updates to manufacturing leadership. Support technology transfer and operational readiness activities for pipeline products. Perform additional manufacturing and project-related activities as needed.

Required Qualifications:

5+ years of relevant manufacturing experience with a High School Diploma, OR a Bachelor's degree in a relevant science or engineering discipline. Hands-on experience in GMP/cGMP manufacturing. Experience with aseptic techniques and ISO 5 cleanroom operations. Experience working with primary human cell cultures. Strong understanding of GMP processes and biologics manufacturing. Experience supporting cell therapy manufacturing and/or technology transfer. Ability to independently troubleshoot and resolve complex manufacturing issues. Strong documentation and communication skills. Ability to work effectively in a highly regulated manufacturing environment.

Preferred Experience:

CAR-T, TCR-T, or allogeneic cell therapy manufacturing Cell therapy production operator/verifier/runner experience GMP clinical or commercial manufacturing CMC regulatory framework for biologics Manufacturing Sciences & Technology (MSAT) Process Development (PD) Deviation/investigation support Manufacturing technology transfer (LH-R6) #IND2

Pay:

$22.00 - $23.00 per hour

Benefits:

401(k) Dental insurance Health insurance Referral program Vision insurance Application Question(s): How many years of cell therapy manufacturing experience do you have? Do you have hands-on experience working in a GMP/cGMP manufacturing environment? Do you have hands-on experience with aseptic processing and ISO 5 cleanroom operations? Do you have experience manufacturing cell therapy products, such as CAR-T, TCR-T, or allogeneic cell therapy? Have you operated cell-processing equipment such as Sefia, Finia, Sepax, NC-200 Nucleocounter, Dynasellect, Cue, Welder, or Sealer? Are you able to work Monday-Friday, 8-hour shifts, with the possibility of transitioning to a 4x10 schedule (Sunday-Wednesday or Wednesday-Saturday)? Are you a US Citizen or GCH? If on Visa please mention the Visa Status. Are you ready for background check and drug screen in accordance with the local law and regulations? Please confirm your email address and contact number. Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy? What is your Expected Pay Range?

Work Location:

In person