As an MSAT USP Process Leader (Expert), you will be responsible for coordinating and leading activities related to USP process transfer and validation, reviewing and analyze data related to the production of monoclonal antibodies at USP stages as part of process transfer, process scaling, GMP production and process validation.
You will also participate Participation in the transfer of technology/process validation in accordance with cGMP and internal regulations in the implementation of projects related to the introduction of new biotech products.
- Reviewing Process Design to ensure facility fit/suitability for GMP for internal projects.
- Evaluating USP new technology / defining desired platform technology.
- Reviewing/participating in preparation of the USP Process Transfer documentation (protocols, reports, risk assessments, process descriptions).
- Reviewing of the USP documentation package delivered by the Sending Unit including Review of Process Characterisation Studies & SDMQ.
- Supporting deviations investigation, change control assessment, CAPA implementation concerning process transfer, validation and GMP batches.
- USP Batch Record Data Review and Assessment.
- Set up and coordination USP Lessons Learned Sessions post-process transfer.
- Generating/reviewing USP PV documentation including protocols, Risk Assessments related to PV, and reports.
- Participating in USP early process design and USP RCI for deviations.
- Completed studies in biotechnology, pharmacy or related discipline.
- A minimum of 6 years of experience in the production of biotechnology products at production or semi-production scale, participation in the transfer and scale-up activities of production processes related to USP stages of the cell culture manufacturing process and or microbial manufacturing process.
- Fluent English
- Experience with working in cGMP environment.
- Ideally experience with process validation according to FDA and EMEA guidelines.
- Experience with single-use technology is a plus.
- Competitive salary.
- Lunch card.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- English learning platform.
- Multisport card.
