Job Description

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.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

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 responsibilitie
• 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.

• Minimum Required Qualifications/Skills:

• BS Preferred, additional experience in lieu of degree considered
• Minimum 5 years related experience with degree, minimum 8 years without degree

Supervision Received

The incumbent establishes methods and procedures for attaining specific goals and objectives and receives guidance in terms of broad goals. Only the final results of work are typically reviewed.

Essential Job Functions

The demands described below are those essential functions that an employee must be able to accomplish in order to perform this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Marginal or non-essential functions should not be listed. Please note that regular and reliable attendance is an essential function of every position and should not be listed separately below.