Cell Therapy Manufacturing Leader

Lonza; Portsmouth (NH); Presencial; USD 120.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Disability insurance

Employee assistance programs

Paid time off

Descripción de la vacante

Lonza in Portsmouth, NH seeks a Manufacturing Manager to lead cell therapy manufacturing operations, ensuring a safe, compliant, and efficient production environment. You will serve as a subject matter expert and guide teams through critical production activities.

You will oversee process transfers, quality systems, and continuous improvement initiatives while collaborating with QA, IPTs, and stakeholders to maintain production alignment and program success.

Formación

• Bachelor’s degree preferred; equivalent industry experience may be considered in lieu of a degree.
• Experience leading manufacturing operations within biopharmaceutical, biologics, cell therapy, or related GMP-regulated environments.
• Demonstrated leadership experience managing teams, organizational change, hiring, training, and employee development.
• Experience supporting technical transfers, project execution, and commercialization of manufacturing processes.
• Strong knowledge of cGMP requirements, quality systems, deviation management, and manufacturing compliance expectations.
• Experience with biological manufacturing operations, including fermentation, purification, drug product filling, freezing operations, or related modalities.
• Experience with automated drug product filling systems utilizing RABS and/or isolator technology preferred.
• Experience with automated or manual visual inspection systems preferred.
• Strong business acumen, customer focus, collaboration, and ability to drive results in a fast-paced manufacturing environment.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Proven ability to manage priorities, budgets, continuous improvement initiatives, and operational performance metrics.

Responsabilidades

• Provide a safe, controlled work environment and ensure site safety objectives are communicated and understood by all manufacturing personnel.
• Lead manufacturing teams and serve as the subject matter expert for assigned operations, including Cell Growth and Drug Product Filling.
• Provide in-suite oversight during critical manufacturing activities such as harvest, vial filling, visual inspection, and other key production operations.
• Support technical transfer activities, including process execution, methods transfer, engineering runs, training runs, water runs, and qualification activities.
• Collaborate with Quality Assurance and cross-functional teams to establish procedures, quality systems, and manufacturing strategies for new and existing programs.
• Partner with Internal Project Teams (IPTs), Joint Project Teams (JPTs), customers, and stakeholders to successfully transfer and maintain processes in the manufacturing facility.
• Own and manage manufacturing-related deviations, change controls, and lessons learned activities while supporting continuous improvement initiatives.
• Support hiring, development, training, and performance management of manufacturing staff while fostering a high-performing team culture.
• Collaborate with Manufacturing Technical Managers to identify equipment, material, and resource requirements needed to support production operations.
• Partner with leadership to ensure accurate financial reporting, project progression, proposal support, and operational execution across Cell Therapy programs.
• May serve as delegate for the Manufacturing Director during periods of absence.

Conocimientos

Leadership

Manufacturing operations

cGMP knowledge

Quality systems

Deviation management

Project execution

Stakeholder management

Communication

Educación

Bachelor’s degree

Herramientas

RABS

Isolator technology

Descripción del empleo

Lonza in Portsmouth, NH seeks a Manufacturing Manager to lead cell therapy manufacturing operations, ensuring a safe, compliant, and efficient production environment. You will serve as a subject matter expert and guide teams through critical production activities.

You will oversee process transfers, quality systems, and continuous improvement initiatives while collaborating with QA, IPTs, and stakeholders to maintain production alignment and program success.