Technical Support Lead Scientist, MSAT
Technical Support Lead Scientist, MSAT
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.
We have an opportunity for a Technical Support Lead Scientist to join our MSAT team, to be based on site at our fantastic offices in Slough.
The role of the Technical Support Lead Scientist is to support the commercial process validation and on-going technical analysis of process data, trending and reporting.
- Process validation and on-going technical analysis of process data, trending and reporting using the internal data systems; DataMart and Statistica analytics software
- Support Continuous Process Verification (CPV) work stages which is a regulatory requirement
- Support Senior Technical Subject Matter Experts (SME’s) in the MSAT team to complete these activities with both internal and external customer input
- Responsible for the design, construction and on-going maintenance of a process database using the DataMart software for the recording of historical GMP (Good Manufacturing Practice) data from batch records working with SME network to align functionality and adopt best practice
- Be responsible for the compliance of the database with regards data integrity working with QA and MSAT management
- Train the Operations personnel in the data entry of GMP process data from batch records into the DataMart system
- Support CPV activities through generation of analytical queries using SQL and the Statistica software package
- Use the database/software to generate statistical process control charts of critical process parameters for SME analysis and interpretation
- Provide documented technical guidance and procedures to train other team members in data system management
- Working with the SME technical team, identifies the completion of continuous improvement activities including GMP batch documentation and technical report generation using the databases and software systems
What we are looking for:
- BSc in Science, Engineering or equivalent discipline or equivalent means of demonstrating ability with significant experience in industry.
- Knowledge of area of expertise through on the job experience or training in (fermentation / purification) operations with a basic understanding of process and equipment operations and GMP.
- Experience of performing data collection, data preparation and subsequent statistical analysis
- Statistical Process Control (SPC) with experience in relevant statistical software packages
- Ability to work and plan own workload with sound understanding of data and software systems.
- Can understand and interpret process data, including experience of data visualization
- Experience of interpreting and communicating data analysis
- Can project manage and author technical GMP documentation
- Highly proficient in Microsoft Excel (Macros, VBA)
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.