GMP Manufacturing Supervisor

4 weeks ago


Portsmouth, New Hampshire, United States Lonza - NAM Full time
Job Summary

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

Key Responsibilities
  • Coordinate and support the execution of production activities for all Cell and Gene processes at LPO.
  • Understand the needs of module-specific processing activities and communicate those needs to manufacturing associates on the production floor.
  • Facilitate the set up and execution of manufacturing procedures to comply with ET & site quality systems.
  • Develop the manufacturing team to meet the 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.
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.

Requirements
  • BS 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.
About Lonza - NAM

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.



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