Job Description
Qualifications
Experience of biological GMP manufacturing operations in particulars Fermentation, Purification, Drug Product Filling and Freezing processes
Minimum 5 years related experience with degree, minimum 8 years without degree
Responsibilities
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)
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
Job description
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, ****** orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law
Experience of biological GMP manufacturing operations in particulars Fermentation, Purification, Drug Product Filling and Freezing processes
Minimum 5 years related experience with degree, minimum 8 years without degree
Responsibilities
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)
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
Job description
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, ****** orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law
💡 Quick Summary
Seeking a career-building opportunity? The GMP Production Supervisor position is now open for candidates interested in the Manufacturing Jobs sector. This role in Hampton Falls offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Manufacturing Jobs is a plus.
