Bio 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 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, cleaning and maintenance of equipment and ensures equipment is ready for production operations.
- Performs routine sanitization.
- Maintains inventory of equipment and supplies, ensuring availability for production activities.
- Performs qualification/validation processes to maintain validity of manufacturing processes.
- Monitor 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.
Experience and Skill Requirements
- 2+ years’ experience in FDA current Good Manufacturing Practices for product manufacturing is preferred but not required.
- Required to work in cleanroom conditions performing aseptic and sterile operations for 2-3 shifts, 1-2 times per day during production. Cleanroom gowning requirements entail changing out of street clothes, into hospital scrubs followed by an additional layer of sterile garments covering head to foot along with protective face and eyewear.
- Working in a Bio Safety Level II environment.
- Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and have 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. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
- Must be able to pass a criminal background check and meet all training requirements. In accordance with the occupational safety requirements, may be required to have medical testing and/or vaccinations.