cGMP Biotech Production Technician
Rochester, MN (Required)
Reports to Director, Mfg Operations
The cGMP Biotech Production Technician will be responsible for manufacturing of oncolytic viruses and other biologics for clinical trials, as well as preclinical process development. The GMP Biotech Production Technician plays a vital role in the day-to-day manufacturing operations in compliance with cGMP standards. Bioproduction involves aseptic processing in a pharmaceutical cleanroom facility, large-scale cell culture, vector generation, purification, concentration, and fill and finish operations, according to established standard operating procedures (SOPs). In addition, staff are responsible for the daily operations and environmental monitoring of the GMP facility to ensure compliance with applicable regulations.
- Performs all aspects of cGMP manufacturing of clinical grade viruses and viral vectors following established SOPs.
- Performs preclinical grade viral vector production, scale-up and process development.
- Reviews, edits, completes and revises batch records, worksheets and SOPs in accordance with Good Document practices.
- Prepares reagents and ensures inventory for the manufacture of clinical and preclinical viral vectors.
- Performs set up, dismantling, and maintenance of equipment and ensures equipment is ready for production operations.
- Performs manufacturing level maintenance on equipment.
- Participates in equipment installation, commissioning and validation.
- Maintains manufacturing equipment and records.
- Participates in quality control testing of clinical and preclinical grade vectors.
- Assists with facility cleaning, changeover, and staging of materials.
- Collaborates closely with the process development, Quality Control and Quality Assurance teams.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Provide technical representation during internal and external audits.
- Keeps up to date with current technologies and trends in drug product processing.
- Perform routine tasks including general housekeeping, equipment monitoring and maintenance.
- Life sciences degree (Bachelors) in Scientific, Engineering or Healthcare subject area. Experience with upstream and/or downstream manufacture and testing of biologics under cGMP compliance is high desirable.
Experience and Skill Requirements
- Prior laboratory experience in research and/or analytical technique desirable.
- Viral vector production experience highly desirable.
- Ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
- Excellent documentation skills including comprehension, review and establishing Batch Production Records, SOPs, deviations and summary reports.