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Job Title:

Manufacturing Specialist Job Location:

Tarzana

CA 91356

(100% Onsite)

Duration:

90-Days contract (High potential for long-term extension and permanent based on performance)

Shift:

Monday-Friday, 8 hours/day; may change to 4×10-hour shifts (Sun-Wed or Wed-Sat).

Job Summary:

We are seeking a Contract Manufacturing Specialist to support the production of TCR-T, CAR-T, and allogeneic cell therapy products in compliance with cGMP. The role is based in Tarzana, CA, with occasional travel to Santa Monica, CA. The Specialist will support manufacturing operations, product release, operational readiness, and technology transfer activities. This is a 90-day contract with possible extension based on business needs.

Job Responsibilities:

Using general application of principles, support activities to ensure GMP readiness for clinical manufacturing, including but not limited to equipment procurement, installation and qualification, facility qualification, and technology transfer. Perform operational tasks within a cleanroom environment in a manner consistent with safety policies, quality systems, and cGMP requirements. Assist in developing Standard Operating Procedures (SOPs) and other documents for manufacturing processes. Set up manufacturing areas and equipment, including complex automated cell processing equipment. Follow all cleaning and gowning procedures for the facility. Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities. Ensure all materials and equipment are identified and available in time for manufacturing activities. Support Process Development (PD) and Manufacturing Sciences & Technology (MSAT) to align manufacturing plans with product development plans. Ensure that all production operations are controlled and performed within cGMP regulatory guidelines. Provide verbal and written updates to Manufacturing leadership. Perform other responsibilities and project-based assignments as needed to support manufacturing operations.

Required Experience and Education:

Minimum of five (5) years of experience with a High School Diploma OR a BS/BA in a relevant science or engineering discipline. Understanding of cGMP process and knowledge of CMC regulatory framework for biologics. Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations. (YR-R6) #IND1

Pay:

$20.00 - $24.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Referral program Vision insurance Application Question(s): 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? Do you have 5+ years of relevant manufacturing experience with a High School Diploma, OR a BS/BA in a relevant Science/Engineering field? Please mention your degree/company and dates. Do you have hands-on experience working in a cGMP/GMP-regulated manufacturing environment? Please mention the client/company where you gained this experience. Do you have hands-on experience with aseptic techniques for primary human cell cultures and/or cell therapy manufacturing? Please mention the client/company where you gained this experience. Do you have experience supporting technology transfer and GMP clinical/commercial manufacturing operations for biologics or cell therapy products? Please mention the client/company where you gained this experience.

Work Location:

In person