Job Title: Manufacturing Cell Processing Specialist III

Job Description

The Manufacturing Cell Processing Specialist III plays a pivotal role in advanced manufacturing operations, focusing on cell processing activities while ensuring compliance with cGMP guidelines. This position involves operating and maintaining production equipment such as control rate freezers and orbital shakers, performing final product freezing and storage, and driving continuous improvement. The specialist is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

Responsibilities

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and manufacturing standards.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment such as control rate freezers and orbital shakers, ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards.
• Revise, update, and ensure adherence to SOPs, batch records, and MS forms to maintain GMP compliance.
• Lead routine cycle counts and ensure accurate inventory tracking and control.
• Execute transactions within the ERP system, including material requisitions and production tracking.
• Ensure accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices.
• Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as required.
• Drive continuous process improvement, incident investigations, and deviation resolutions.
• Ensure all activities comply with safety policies, rules, and regulations to promote a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Essential Skills

• Proficiency in aseptic techniques and sterile processing.
• Experience in cleanroom environments and cell culture.
• Knowledge of cell biology and molecular biology.
• Familiarity with GMP regulations.
• Ability to troubleshoot production equipment.
• Strong computer skills, including Microsoft Office.
• Expertise in ERP systems.
• Advanced organizational, record-keeping, and time management skills.

Additional Skills & Qualifications

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field preferred; relevant experience may substitute for formal education.
• Preferred minimum of 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 2-3 years of proven expertise in a cGMP-regulated environment.
• Ability to exercise independent judgment and lead teams.

Work Environment

The work environment involves both lab and office settings, specifically within a cleanroom environment classified as level 10k and 100k. Responsibilities include sterile gowning and maintaining certification for sterile gowning. The work schedule is Monday through Friday, with shifts potentially ranging from 7 AM to 3 PM or 10 AM to 7 PM, depending on experience.