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GMP Manufacturing Supervisor

2 months ago

Portsmouth, Virginia, United States Lonza Full time
Job Summary

We are seeking a highly skilled GMP Manufacturing Supervisor to join our team at Lonza. As a key member of our manufacturing leadership team, you will be responsible for coordinating and supporting the execution of production activities for all Cell and Gene processes.

Key Responsibilities
  • Coordinate and support the execution of production activities for all Cell and Gene processes, including pilot runs through GMP manufacturing.
  • Facilitate the set up and execution of manufacturing procedures to comply with ET & site quality systems.
  • Develop the manufacturing team to meet business needs and personal career goals.
  • Support the on-time in full delivery of clinical & commercial material as required.
  • Support and ensure execution of EHS, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management, and EM strategies.
  • Ensure completed administrative duties as required.
  • Understand and utilize the appropriate chain of escalation when necessary.
  • Maintain the manufacturing areas from a cleanliness and 6S standpoint.
  • Coordinate with asset support groups and cross-functional teams to execute process activities.
Technical Transfer Responsibilities
  • Provide oversight and support to the definition and execution of Technical Transfer activities for Cell and Gene Technologies Projects.
  • Attend training activities on new processes to gain familiarity and develop training plans.
  • Identify resources necessary to execute processes from initiation of technology transfer through commercial production.
  • Provide operational input into equipment and material requirements, process execution and optimization, and methods transfer.
  • Review, approve, and own version 1.0 documents resulting from technology transfers.
  • Understand and help execute timely delivery of milestones for the Technology Transfer.
  • Coordinate with asset support groups and receiving technical teams to execute technology transfer and qualification activities.
  • Coordinate logistics of traveling teams, including contacting site technical leads and identifying travel requirements for individuals.
Leadership and Collaboration
  • Collaborate with CT Manufacturing Leadership Team to ensure progression of proposals, SOWs, and change orders.
  • Interact with key external (customer) and internal stakeholders.
  • Perform other duties as assigned.
Requirements
  • BS degree preferred, additional experience in lieu of degree considered.
  • Minimum 5 years related experience with degree, minimum 8 years without degree.
  • Experience of biological GMP manufacturing operations in particulars Fermentation, Purification, Drug Product Filling and Freezing processes.
  • Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred.
  • Experience of automated and manual visual inspection systems preferred.
Quality Responsibility

Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.