Hope Biosciences is a leading biotechnology company specializing in the development and manufacturing of cutting-edge cell therapies. We are dedicated to advancing regenerative medicine and improving patient outcomes through innovative treatments. As we expand our FDA-approved trial programs, we are looking for a dedicated Production Technician to join our team and support the production of Mesenchymal Stem Cell (MSC) therapies for clinical trials, ensuring high-quality production in compliance with Good Manufacturing Practices (GMP).
Position Overview
The Production Technician will play a critical role in the manufacturing process of MSC-based cell therapies for use in FDA-approved trial programs. This position involves hands-on work in a controlled GMP environment, performing cell culture, processing, and production tasks while ensuring adherence to quality standards and regulatory requirements. Additionally, the technician will be responsible for the upkeep and maintenance of GMP manufacturing facilities, ensuring a clean and compliant environment for all activities.
Key Responsibilities
- Cell Therapy Production
- Perform cell culture and processing of Mesenchymal Stem Cells (MSCs) according to established protocols for clinical trial manufacturing.
- Assist in the preparation of media, reagents, and equipment used in the production of MSCs.
- Monitor and document the culture conditions and cell expansion processes to ensure optimal cell viability and productivity.
- Operate equipment such as bioreactors, centrifuges, and incubators in accordance with GMP standards.
- GMP Facility Maintenance
- Assist in the routine maintenance and cleaning of the GMP manufacturing areas to ensure compliance with regulatory guidelines.
- Perform regular environmental monitoring activities (e.g., temperature, humidity, differential pressure, and air quality).
- Maintain equipment according to GMP standards, ensuring proper functioning and documentation.
- Ensure proper storage, handling, and disposal of biological materials in accordance with safety and regulatory standards.
- Documentation and Compliance
- Complete and maintain accurate records for all manufacturing and facility maintenance activities in accordance with GMP requirements.
- Filling out batch records with production activities performed in compliance with quality assurance procedures.
- Assist in the preparation for regulatory inspections and audits by ensuring all activities are well-documented and up-to-date.
- Collaboration and Training
- Work closely with team members and management to ensure smooth operations within the production environment.
- Participate in training activities to stay current on the latest cell therapy production techniques, regulatory requirements, and internal SOPs.
Qualifications
- Associate’s degree or equivalent in life sciences, biotechnology, or a related field with previous experience (1-3 years) in a GMP-regulated manufacturing environment, preferably in cell therapy, biologics, or biotechnology.
- Bachelor’s degree or equivalent in life sciences, biotechnology, or a related field
- Strong attention to detail with excellent documentation skills.
- Hands-on experience with aseptic techniques, and laboratory equipment preferred.
- Knowledge of GMP, FDA, and other relevant regulatory standards in clinical manufacturing.
- Ability to work in a fast-paced, team-oriented environment.
- Flexibility to work on weekends, or extended hours as needed.
Preferred Skills
- Familiarity with equipment such as bioreactors, laminar flow hoods, and centrifuges.
- Knowledge of cleanroom protocols and environmental monitoring.
- Ability to troubleshoot and resolve technical issues related to cell culture and equipment.