GMP Manufacturing Manager

3 days ago

Rye, United States Lonza Full time
GMP Manufacturing Manager at Lonza summary:

The GMP Manufacturing Manager oversees production activities in a GMP environment, focusing on Cell and Gene processes. The role involves coordinating technical transfers, compliance with quality systems, and development of manufacturing teams while maintaining operational efficiency and regulatory standards. The manager also engages with cross-functional teams and external stakeholders to ensure the successful delivery of clinical and commercial materials.

United States, Portsmouth (New Hampshire)

GMP Manufacturing Supervisor - Nights

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key Accountabilities and Duties:
  • Coordinating and supporting the execution of production activities for all Cell and Gene processes at LPO to include:
  • Understand the needs of module-specific processing activities and communicate those needs to manufacturing associates on the production floor. To include 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 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.
  • Coordination with asset support groups and cross functional teams to execute process activities.
  • Provide oversight and support to the definition and execution of Technical Transfer activities for Cell and Gene Technologies Projects at LPO to include:
  • After initiation of technology transfer, 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.
  • Coordination 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.
  • Coordinate with MSAT representative on technology transfer responsibilities
  • As project contributor collaborate with CT Manufacturing Leadership Team to ensure:
  • Progression of proposals, SOWs, and change orders.
  • Appropriate interaction with key external (customer) and internal stakeholders
  • Perform other duties as assigned.
  • Interaction with regulatory agencies preferred
  • Core involvement in Technical Transfer and project activity
  • Leadership of organizational change, staff hiring and training
  • Continuous Improvement activities
  • Generation and optimization of batch documentation (EBR preferred)
  • 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.

Education

BS Preferred, additional experience in lieu of degree considered

Experience

Minimum 5 years related experience with degree, minimum 8 years without degree

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

Reference: R62957
Keywords:

GMP, manufacturing, cell and gene therapy, production management, quality systems, technical transfer, biological manufacturing, team development, EHS compliance, process optimization

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