Lab Technician

Responsibilities

• Demonstrate understanding of GMPs and their application to specific responsibilities.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Follow verbal and written procedures in operating production equipment and perform processing steps; accurately complete appropriate production documentation.
• Maintain cleanliness and orderliness of the process area.
• Ensure the production area is stocked with supplies.
• Perform batch record review, procedure revisions, and work order generation.
• Utilize manufacturing knowledge to improve process operations and effect positive change.
• Support or lead Commissioning and Validation activities.
• Assist in the creation and revision of manufacturing documentation by providing input to technical composition of documents.
• Maintain equipment operation through responsive troubleshooting, repairs, and following operations guidelines.
• Document all production efforts in appropriate logs, forms, reports, and databases.
• Maintain a safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; comply with legal regulations; monitor environment.
• Enhance organizational reputation by striving to meet and exceed performance expectations.
• Identify and assist in the corrective actions of processing-related issues.
• Perform other related duties as assigned to meet departmental and company objectives.
• Assist in the identification and implementation of continuous improvement opportunities.
• Complete tasks in a compliant and safe manner.
• Adhere to all cGMPs, compliance/regulatory mandates, and quality standards.

Essential Skills

• Associate's degree or Bachelor's in science or related field.
• Minimum of 5 years of experience in cleanrooms or manufacturing setting.
• Knowledge of T cell therapy and TCR-engineered T cell therapies.
• Familiarity with GMP, batch record review, and biologics.
• Fluency in reading, writing, and speaking English.
• Experience in reviewing and creating controlled documents.
• Capability to perform required tasks in a compliant manner after safety training.
• Strong documentation and communication skills.
• Ability to lift and transport packages weighing up to 50 pounds.
• Extensive walking throughout the facility.
• Intermediate skills in Microsoft Word, Excel, Outlook, and PowerPoint.