Core Technician– Cell Therapy

Lonza•Houston, TX

4d•Onsite

About The Position

As a Core Technician - Cell Therapy, you will play a critical role in the manufacturing of clinical and commercial cell therapy products within a highly regulated GMP environment. This position is responsible for performing aseptic cell processing activities, operating production equipment, completing GMP documentation, and supporting the safe and compliant manufacture of life-saving therapies. Working closely with Manufacturing, Quality, and Operational teams, you will help ensure products are produced according to established procedures, quality standards, and production schedules.

Requirements

High school diploma or equivalent required; Associate degree in a scientific or technical discipline preferred.
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.
Proficiency with Microsoft Office applications, including Excel.
Strong organizational, time management, and prioritization skills.
Effective verbal and written communication skills.
Ability to work collaboratively within a team environment and resolve issues professionally.
Self-motivated, solution-oriented, and committed to operational excellence.
Ability to perform aseptic gowning on a routine basis.
Ability to stand for extended periods, up to 6 hours.
Ability to routinely lift up to 50 pounds.

Nice To Haves

Experience completing GMP documentation and reviewing manufacturing records is preferred.
Experience with SAP and LIMS is desirable.

Responsibilities

Participate in the aseptic processing and manufacture of clinical and commercial cell therapy products.
Perform aseptic cell culture manipulations within 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 all 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 effectively with Manufacturing, Quality Assurance, Quality Control, and other site functions to support operational objectives.
Perform additional duties as assigned in support of manufacturing operations.