Manufacturing Supervisor, cGMP Production Job at Lonza
United States, Lexington (Massachusetts)
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.
The Manufacturing Supervisor will coordinate and support the execution of production activities of Cell and Gene process at Lonza Lexington to include: Provide a safe, controlled work environment in all areas of responsibility and be aware of the site safety objectives and make sure they are communicated and understood by all staff. Manufacturing Supervisor will be the Point of Contact for the assigned manufacturing processes. They will provide in suite oversight of the manufacturing process during critical operations (i.e. cell expansion, perfusion, clarification, chromatography, UFDF, vial filling, visual inspection, etc.). Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems. Collaborate with Manufacturing Leadership team to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with Manufacturing Manager to determine equipment and materials the suite will need to purchase in order to run the process. May act as fill in for Manufacturing Manager in their absence.
Key Responsibilities:
Understand the needs of 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, Upstream and Downstream DS production, DP Vial Filling, Visual Inspection, APS, Cleaning, Scheduling 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.
Work with Manufacturing Manager to 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.
Create, review and approve 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.
After initiation of technology transfer, attend training activities on new processes to gain familiarity and develop training plans.
Coordinate with MSAT representative on technology transfer responsibilities
As project contributor collaborate with CT Manufacturing Leadership Team to ensure:
Appropriate interaction with key external (customer) and internal stakeholders
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
Experience of biological GMP manufacturing operations in particulars Fermentation, Purification, Drug Product Filling, Visual Inspection.
Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred
Key Requirements:
BS/ BA Degree in a life science discipline preferred.
Five years of experience in biological GMP manufacturing operations in particulars Fermentation, Purification, Drug Product Filling and Visual Inspection processes
Experience with single use technologies is essential.
Core involvement in Technical Transfer and project activity.
Continuous Improvement activities
Generation and optimization of batch documentation
Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred.
Ability to work inter-departmentally and potentially with customers.
Excellent communications skills both verbal and written. Must be proficient with MS Office applications.
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: R52741
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