Biogensandbox

Biogensandbox

Manufacturing Supervisor Upstream

Role

Manufacturing Supervisor Upstream

Job type

Full-time

Posted

83 months ago

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Salary

Not disclosed by employer

Job description

During project phase

  • Leverage Integrated Working Team ( IWT) lead, plan and anticipate resources for upcoming commissioning activities and ensures Manufacturing Associates staffing to support commissioning execution.
  • Drive manufacturing and area (BES Cmg Eng) staff to complete or exceed needed area work as outlined by plan.
  • Drive Operational Readiness activities (SOPs, Material identification, etc.)
  • Own the plant areas to ensure readiness for production

Once operational

  • Schedule and direct daily manufacturing activities in the 18K Cell Culture area
  • Technical responsibilities include, but not limited to, aseptic seed manipulation, Delta V controlled bioreactors, centrifugation, analytical lab equipment for sampling, as well as use of electronic batch documentation
  • Perform manufacturing activities according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution
  • Coordinate and draft revisions to automated batch documents
  • Hire and develop a well-functioning team - focusing on values and culture, including safety and cGMP requirements
  • Establishment of goals and development plans for employees
  • Supervises validation activities, ensuring proper and timely execution of validation protocols
  • Coordinate manufacturing activities with other departments such as Quality, Materials Management, Manufacturing science, Validation, and Process Engineering

This position will require Shift work activities. If you have questions please reach out.

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  • At least 3 years of solid practical experience with similar tasks, preferably with pharmaceutical processing in manufacturing or process development environment -within biotech, pharmaceutical or food production
  • Experience in leading and developing a

Join our new facility that will utilize new technologies pioneered by our experts in technical development and employ an innovative, world-class engineering design to deliver substantially increased productivity. It will initially house two manufacturing cells each containing four 18’000 liters bioreactors.

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