Senior Process Engineer, MSAT (CGT)

Lonza Biologics Porriño SLU; Utah; On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player in life sciences is seeking a skilled professional to lead and support the transfer of innovative manufacturing processes. This role involves collaborating with technical experts, performing critical analyses, and ensuring the successful integration of new processes into production. You will play a vital role in driving improvements and supporting the development of life-saving therapies. Join a team that values creativity and problem-solving, making a meaningful impact on global health and well-being. If you are passionate about science and eager to contribute to groundbreaking advancements, this opportunity is for you.

Qualifications

• 7-10 years of lab experience in biotech or life sciences.
• Understanding of ELISA, potency, PCR, and FACS methods.

Responsibilities

• Lead/support technology transfer of manufacturing processes.
• Perform technical reviews and manage change controls.
• Identify and implement process improvements.

Skills

Problem-solving

Statistical Data Analysis

Technical Review

Process Improvement

Education

Degree in Science

Tools

Excel

TrackWise

Job description

Today, Lonza is a global leader in life sciences operating across five 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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The successful candidate will join the Cell, Gene and Therapy division (CGT). The role will Lead/ Support the timely and successful transfer of customer’s manufacturing process into the Lonza Bioscience Singapore production facility.

Duties and Responsibilities:

• Perform analysis and design of process fit and process-scale up in collaboration with vendors, customer technical experts or Lonza’s Process Development and MSAT teams of other sites.
• Design and perform experiments on scale down process in MSAT lab to support process technology transfer. Follow all applicable lab safety policies.
• Author, review and/or approve process-related documents i.e. Process overview, APS protocols, development/investigative protocols and reports.
• Develop and define training programs and requirements to facilitate integration of new manufacturing processes into Lonza Bioscience Singapore production facility.
• Interact with customer technical experts as necessary to progress technology transfer.

Process Support:

• Perform technical review/approvals of batch records, process SOPs, deviations, change controls, training documents, protocols, development/investigative reports, CAPAs.
• Support investigations into process issues/deviations and if required, coordinate the associated troubleshooting activities and/or perform experiments in the MSAT small-scale cell culture process lab. Follow all applicable lab safety policies.
• Manage change control implementation for process changes that are driven by process changes/improvements and coordination of non-GMP and/or non-clinical runs.
• Lead/support pre-campaign preparation activities. Oversight on the production floor to provide support and review of operations. Escalate issues to management appropriately and interface with customer on issue resolution.
• Oversight of ongoing trainings to ensure alignment between training and process requirements.
• Monitor manufacturing run process data and monitor for run-to-run consistency.
• Identify and drive implementation of process improvements as required. Support inspections and audits by customer and regulatory authorities as required.
• Support plant start-up and pilot/clinical/commercial run. Perform technical investigations and help author technical reports to support close-out of deviations, troubleshoot process excursions/issues in operations, and participate in the generation and assessment of required change controls.
• Able to recognize abnormalities and/or potential events that might affect process, product quality and/or safety & escalate promptly to the appropriate level for attention.

Requirements:

• Degree in a relevant Science field or Equivalent. Relevant 7-10 years work experience in Lab experience in a biotech or development services, R&D, healthcare and life sciences field would be an advantage. Knowledge of Excel as well as Statistical Data Analysis tools.
• Bio Assay Area: Understanding and execution of ELISA, potency, PCR and FACS methods.
• Experience in using TrackWise to perform change control, effectiveness check, corrective actions and preventive actions (CAPAs) is highly desirable.
• Problem-solving tools such as 5 Whys, 5M, fishbone diagrams to identify root causes.

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.