At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
As a member of the MSAT (Manufacturing Science & Technology) Team, you are the primary technical support person for manufacturing processes and perform technical administration activities to assist and support the process transfer or process manufacturing activities in the site in compliance with cGMP and customer requirements in respect of timing, accuracy and availability of information.
Key Accountabilities and Duties
- Performs most of the functions associated with process support, e.g. develop process understanding, modify / review Process Descriptions and Batch Records, author / review change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release.
- Investigates deviations and assesses non-product quality impacting deviations.
- Performs intermediate level data analysis such as non-standard calculations, means comparison, control charting.
- Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently. Assesses change controls for impact of any change to the process, equipment or procedures with assistance.
- Represents MSAT on project teams and interfaces with customer technical and quality representatives. Represents MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings).
- Participates in Customer Audits.
Qualifications and skills required
- Bachelor of Science, Field of Study Biological Sciences or Chemical Engineering
- More than 5 years of experience in the production of biopharmaceuticals (Upstream/ Downstream)
- Experienced in aseptic technique and familiar with protein characterization assays.
- Understanding of GMP regulations
- Fluency in English and Spanish
- Communication, technical writing, organizational and interpersonal skills.
- Computer skills (including Word, Excel, Outlook and PowerPoint).
- Analytical and problem solving skills.
- Attention to detail and high level of accuracy.
Lonza. The place to Go, Stay and Grow.