Core Technician– Cell Therapy

Lonza•Houston, TX

6d•Onsite

About The Position

The Core Technician – Cell Therapy plays a critical role in manufacturing clinical and commercial cell therapy products in a highly regulated GMP environment. The role performs aseptic cell processing activities, operates production equipment, completes GMP documentation, and supports the safe and compliant manufacture of therapies. Working with Manufacturing, Quality, and Operational teams, the technician helps ensure products are produced according to established procedures, quality standards, and production schedules. This is an on-site position in Houston, Texas.

Requirements

High school diploma or equivalent.
1–2 years of experience working with cell therapy technologies or related biopharmaceutical manufacturing processes in a cGMP environment.
Working knowledge of aseptic processing principles and cleanroom operations.
Ability to perform aseptic manipulations while maintaining product and environmental integrity.
Ability to read, understand, and follow SOPs, manufacturing instructions, and production schedules.
Understanding of cGMP requirements and the importance of regulatory compliance.
Strong organizational, time management, and prioritization skills.
Effective verbal and written communication skills.
Ability to collaborate within a team environment and resolve issues professionally.
Self-motivated, solution-oriented, and committed to operational excellence.
Ability to perform aseptic gowning routinely.
Ability to stand for extended periods, up to 6 hours.
Ability to routinely lift up to 50 pounds.

Nice To Haves

Associate degree in a scientific or technical discipline.
Experience completing GMP documentation and reviewing manufacturing records.
Proficiency with Microsoft Office applications, including Excel.
Experience with SAP and LIMS.

Responsibilities

Participate in the aseptic processing and manufacture of clinical and commercial cell therapy products.
Perform aseptic cell culture manipulations in Grade A/B cleanroom environments.
Operate cell processing and manufacturing equipment according to approved SOPs.
Troubleshoot basic equipment issues and escalate concerns as appropriate.
Follow contamination control and containment strategies to maintain a compliant GMP manufacturing environment.
Participate in assigned customer Aseptic Process Simulations (APS).
Complete GMP documentation accurately, thoroughly, and in a timely manner.
Review manufacturing batch records (MBRs) and related GMP documentation as required.
Adhere to safety policies, procedures, and applicable regulations.
Identify, document, and communicate deviations from standard procedures and accepted practices.
Provide accurate information and support during process deviation investigations.
Follow production schedules and execute assigned manufacturing activities efficiently.
Collaborate with Manufacturing, Quality Assurance, Quality Control, and other site functions to support operational objectives.
Perform additional duties as assigned in support of manufacturing operations.