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cGMP Biotech Production Lead

Rochester, MN (Required)

Reports to Director, Mfg Operations

Full-time

The cGMP Biotech Production Lead will be responsible for leading a team of four bioproduction technicians to perform cGMP manufacturing of oncolytic viruses and other biologics for clinical trials. The GMP Biotech Production lead will work closely with the Director of Manufacturing to coordinate manufacturing schedules, inventory, facility operations, and 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). The lead will ensure daily operations and environmental monitoring of the GMP facility are in compliance with applicable regulations.

Key Responsibilities

  • Coordinate, supervise and train a team of bioproduction technicians to perform all aspects of cGMP manufacturing of clinical grade viruses and viral vectors following established SOPs.
  • Performs clinical and 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.
  • Collates data from quality control testing of clinical and preclinical grade vectors.
  • Coordinate facility cleaning, changeover, and staging of materials.
  • Collaborates closely with the process development, Quality Control and Quality Assurance teams. 

Other Responsibilities:

  • 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.

Educational Requirements

  • Life sciences degree (Bachelors or Masters) in Scientific, Engineering or Healthcare subject area.

Experience and Skill Requirements

  • At least 4-5 years’ experience with upstream and/or downstream manufacture and testing of biologics under cGMP compliance is required.
  • Viral vector production experience highly desirable.
  • Prior laboratory experience in research and/or analytical technique desirable.
  • Prior experience in supervising and coordinating a team 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.

Apply today

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

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Work authorization:

By joining Vyriad, you will work alongside some of the world’s experts in virotherapy at the forefront of creating engineered replication competent viruses designed to destroy cancer selectively and rapidly. We have created a culture that empowers our teams and our teammates to have the biggest impact and to explore their interests and capabilities. We prize freedom with accountability and offer significant flexibility, along with excellent benefits and competitive compensation in a fast-growing organization.