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cGMP Production Technologist

Rochester, MN

Reports to Director of Manufacturing Operations

Full-time

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.

Key Responsibilities

  • 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.

Other Responsibilities:

  • 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.

Educational Requirements

  • 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.

Apply today

To apply, please send your resume and cover letter to careers@vyriad.com

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