Cell Culture Manufacturing Technician
3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues.
The Cell Culture Manufacturing Technician will be responsible for the performance of manufacturing and the processing and general testing of cell cultures for development, pilot, and cGMP aseptic manufacturing in accordance with well-defined standards and procedures. This individual will be expected to actively participate within the team and assist in creating a positive work environment. This individual may also provide support to other groups such as Quality Control, Quality Assurance, and Research.
This position will support both Operations and Development and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance.
1 - 3 years of experience in aseptic biopharmaceutical manufacturing is required. The Technician will be trained in bioprocessing procedures, and how to use and interpret analytical equipment and results.
- Perform internal manufacturing, testing, labeling and packaging of intermediates. Serve as the primary operator or as the secondary verifier.
- Perform monitoring of facility, equipment, and utilities to ensure uninterrupted operations.
- Ensure clear, documentation of all activities in accordance with current Good Manufacturing Practices to comply with regulatory requirements.
- Participate in batch record review as required by Quality and Production management
- Identify any issues and escalate to leadership and Quality Assurance. Work with leadership and team to address issues in a timely fashion.
- Support the ordering, handling, labeling, and documentation of raw materials used for manufacturing of internal products.
- Provide support for manufacturing facility development, buildout, commissioning and qualification activities.
- Maintain the laboratory in a safe, clean, and orderly manner.
- Dispose of and work alongside chemical and biohazardous material.
- Support and respond to after-hour alarms and/or other job critical tasks
- Support operations and development in performing equipment calibration, certification and qualification, as appropriate, and maintain compliance with systems.
- Support compilation of manufacturing metrics, data, reporting and process improvements.
- Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
- Stay current with company SOPs, batch records and industry standards, and all applicable regulations.
- Mandatory aseptic processing and cell culture processing in combination with cell culture equipment experience
- Minimum of 3+ years of cGMP experience preferred; pharmaceutical / biotechnology or similar manufacturing environment.
- Mandatory: 1-3 years in aseptic biopharmaceutical manufacturing (preferably in biologics/cell therapies).
- Previous experience with cell therapy products
- Experience in handling and propagation of human primary cells or other mammalian cells
- Rigorous adherence to SOPs and cGMP regulations, with the ability to accurately complete documentation associated with commercial manufacturing
- High School Diploma or Equivalent required, Bachelors in Life Science or Engineering preferred
- Attention to detail and ability to follow clear written documentation.
- Use of basic computer software such as Microsoft Office
- Requires some heavy lifting, moderate levels of standing and is physically demanding.
- Requires legible handwriting and good eye-hand coordination skills.
- Strong ethical foundation
- Experience with the aseptic manufacturing of Advanced Technology Medicinal Products preferred.