Job Description
The QA Operations Sr. Associate I assures that all operations meet or exceed cGMP regulations ensuring the quality of Cell Banks and Bulk Drug Substance supporting on shop floor the daily upstream manufacturing and facility operations.
The position needs reactive support of discrepancy identification on cell culture and fermentation processes, resolution on the floor, root cause analysis and corrective action for product and process related non-conformances. The holder will collaborate with product Quality Management for change control. This is accomplished by direct collaboration and oversight of Manufacturing Operations and the review/audit of data and reports as specified by Standard Operating Procedures. This position will support quality key metrics and analysis.
This role is expected to be cross-functional between the Luterbach Quality and site organization, and all parts of the quality line organization (QC, Corporate Quality and QA) as well as relevant partner departments.
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Qualifications
The position is expected to have expert level knowledge in cell culture , fermentation , operations and business processes within a GMP Biotech environment. Previous experience with manufacturing execution systems (Delta V/Syncade) as well as Trackwise, LIMS, electronic documentation and training systems will be an advantage. As the facility is designed to be a high-throughput facility it will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.
- Approximately 3 to 5 years of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environment.
- Prior experience with fully electronic operations and management is preferred.
- Good experience of process design and improvement.
- Strong working experience with GxP regulations
- Electronic Batch Record and elogbook management will be an asset
Education
Bachelor in Science / Engineering in Life Science or Technical discipline
Biogen is one of the world’s leading biotechnology companies which is expanding its business in biotechnology.
This Biogen facility in Luterbach, near Solothurn, will be a state-of-the-art building that brings Biogen’s latest progress in biologics manufacturing technology to reality.
The facility combines Biogen’s latest technology in terms of fed-batch cell culture technology and high-performance purification. It will allow manufacturing of biopharmaceuticals at a large scale.
In the Quality Operation team you will participate to an incredible journey by supporting the facility construction and the operational activities in the near future.
As we are interviewing on an ongoing basis, please apply as soon as possible.