cGMP Production Technologist
Reports to Director of Manufacturing Operations
Production staff are responsible for highly complex and specialized manufacturing of virotherapy products for clinical trials as well as support for pre-clinical product development. In addition, staff are responsible for the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations.
- Manufactures product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
- Performs set-up, dismantling, and maintenance of equipment and assures equipment is ready for production operations.
- Performs routine sanitization of areas.
- Performs equipment maintenance, such as periodic equipment cleaning, inspection, etc.
- Maintains inventory of equipment and supplies ensuring availability for production activities.
- Performs qualification/validation processes to maintain validity of manufacturing processes.
- Monitors production processes for compliance with processes and procedures and participates in non-conformance and complaint investigations, and develops, coordinates and implements corrective and preventive actions.
- Assists Quality Assurance staff in collating records for the final batch record review, as needed.
- A bachelor’s degree in a science-related field is required with a minimum of 2 years’ experience in a GMP manufacturing role.
Experience and Skill Requirements
- Experience in FDA current Good Manufacturing Practices for product manufacturing is required.
- Exceptional human relations and communication (written, verbal, and listening) skills are required.
- Detail-oriented with the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations.
- Ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Flexibility to adapt to a variety of responsibilities, work assignments, and priorities.