GMP Production Lead

public client lonza display name
US - New Hampshire - Rye
February 1, 2025

GMP Manufacturing Supervisor - Night Shift

Join Lonza, a global leader in life sciences, as we leverage science to develop innovative solutions that improve lives. We believe in empowering our talented workforce, allowing them to influence and own their career paths while making a meaningful impact.

Key Responsibilities:

Coordinate production activities for Cell and Gene processes, including pilot runs through GMP manufacturing.
Communicate processing needs effectively to manufacturing associates on the production floor.
Ensure compliance with manufacturing procedures and site quality systems.
Develop and mentor the manufacturing team to meet business and individual career objectives.
Support the timely delivery of clinical and commercial materials.
Ensure adherence to EHS, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management, and EM strategies.
Oversee administrative tasks as required.
Utilize the appropriate escalation pathways when necessary.
Maintain cleanliness and organization in the manufacturing areas through 6S practices.
Coordinate with asset support groups and cross-functional teams to execute production activities.
Provide oversight for Technical Transfers of Cell and Gene Technologies, including creating and executing training plans.
Identify resources for process execution from initiation through commercial production.
Participate in developing operational input for equipment, materials, and methods transfer.
Review and approve version 1.0 documents from technology transfers.
Ensure timely delivery of milestones concerning technology transfers.
Facilitate logistics for traveling teams, including arrangement of travel requirements.
Work alongside MSAT representatives on technology transfer responsibilities.
Collaborate with the CT Manufacturing Leadership Team on proposals, SOWs, and change orders.
Engage with key stakeholders, both internally and externally.
Undertake other duties as assigned, including regulatory interactions and technical project involvement.
Lead initiatives for organizational change, staff recruitment, and training.
Participate in Continuous Improvement efforts and batch documentation optimization.
Experience in biological GMP manufacturing, particularly with Fermentation, Purification, Drug Product Filling, and Freezing processes preferred.
Experience in Autologous environments and innovative resourcing solutions preferred.
Familiarity with automated and manual visual inspection systems is advantageous.

Quality Commitment:

Adherence to cGMP standards is mandatory throughout the manufacturing of APIs. Each team member is accountable for the quality of their output and must promptly report any regulatory inspections, GMP deficiencies, or product defects to management.

Education Requirements:

A Bachelor's degree is preferred, although equivalent experience will be considered in lieu of a degree.

Experience:

A minimum of 5 years of relevant experience required with a degree, or 8 years without one.

At Lonza, we positively impact the lives of millions through our products and services, which is both a privilege and a responsibility. Our ethical practices are an integral part of our success. We value creativity and problem-solving in the life sciences sector. Help us continue making a significant difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, veteran status, or any other characteristic protected by law.

Read the full job description and apply online on the recuiter's web-site

GMP Production Lead

GMP Production Lead

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