Cell Therapy Specialist

Job Title:

Cell Therapy Specialist

Job Description

The Cell Therapy Specialist plays a key role in the GMP manufacturing of cutting-edge cell therapy and biologic products for clinical use. In this position, you execute manufacturing batch records and standard operating procedures, support technology transfer activities, and help ensure that all production operations comply with cGMP and good documentation practices. You contribute directly to the development and production of advanced RNA and cell therapies that aim to provide safer, more effective treatment options for patients with autoimmune diseases.

Responsibilities

+ Execute manufacturing batch records and standard operating procedures (SOPs) for the production of clinical cell therapy and biologic material in a GMP environment.

+ Provide expert consultation and hands-on support for technology transfer activities to the MSAT (Manufacturing Science and Technology) team.

+ Develop a deep understanding of the manufacturing processes and equipment used for clinical material production, including cell culture and aseptic operations.

+ Assess, troubleshoot, and resolve common problems that arise during cell therapy product manufacturing, escalating issues as appropriate.

+ Ensure full compliance with cGMP standards and good documentation practices (GDP), and support internal site audits as needed.

+ Complete advanced training on relevant SOPs and subsequently train other team members on proper execution and compliance.

+ Author, review, and revise SOPs related to cell therapy and biologics manufacturing to maintain accurate and current procedures.

+ Document deviations and corrective and preventive actions (CAPAs), investigate root causes, resolve issues, and propose process improvements.

+ Maintain accurate and complete batch records, logs, and associated manufacturing documentation in accordance with cGMP requirements.

+ Ensure all manufacturing supplies and materials are replenished, properly staged, and prepared for cleanroom use.

+ Assist in maintaining a steady supply of raw materials and consumables by identifying and evaluating alternative products and suppliers when necessary.

+ Set up, operate, and monitor complex manufacturing equipment used in cell culture, aseptic processing, and biologics production.

+ Handle biological materials safely within a cleanroom environment, following all safety, environmental, and health guidelines.

+ Adhere strictly to company policies, procedures, and regulations related to safety, quality, and GMP compliance.

+ Work the assigned shift schedule and support occasional weekend and holiday production activities as required.

Essential Skills

+ Hands-on experience in cleanroom operations, including working in controlled environments and following aseptic techniques.

+ Proficiency in executing and managing manufacturing batch records and associated cGMP documentation.

+ Practical experience in cell culture techniques, including handling suspension cells and small-scale cultures.

+ Demonstrated experience in aseptic processing and GMP production of biologics and/or cell therapy products.

+ Knowledge of biologics manufacturing processes, cell therapy production, and good documentation practices (GDP).

+ Ability to follow, understand, and adhere to cGMP manufacturing documentation and SOPs with high attention to detail.

+ Strong troubleshooting skills with the ability to assess and resolve issues in biologics manufacturing and cell therapy production.

+ Capability to document deviations and CAPAs, support investigations, and contribute to continuous process improvement.

+ Competence in sterile gowning procedures and maintaining aseptic qualifications in a cleanroom environment.

Additional

Skills & Qualifications

+ Bachelor's degree in Life Sciences or Engineering, or equivalent combination of education and experience.

+ At least 2 years of experience in cGMP production of biologics, preferably with direct cell therapy manufacturing experience.

+ Significant knowledge of biologics manufacturing processes, cell culture operations, and/or cell therapy production workflows.

+ Excellent documentation skills, including accurately…