The main responsibilities for the Associate III Quality Control will include sample management related activities at Biogen’s new large scale manufacturing facility in Solothurn, Switzerland. The Associate III Quality Control will be accountable for the management of retain samples (drug substance), coordination with Manufacturing Science of laboratory autoclave and glass washing, sample management of stability samples (shipments and supervision of pull dates), intra-site sample and test solution logistics as well as lab reagent ordering, management and distribution. The Logistics/Sample Management team will have the core accountability for maintaining the sample management process and providing technical support. The Associate III will support troubleshooting related to samples and equipment alarm management and plan and execute small improvement project within sample management.
Work in-progress (WIP) laboratories will be embedded into, or adjacent to, the manufacturing workspace at Biogen’s new facility. All operations at the facility will be focused on batch production and release of the drug substance materials produced at the site. It will be the responsibility of the Logistics/Sample Management Team that the WIP laboratories and the central laboratory are supplied with test solutions and reagents in order to ensure timely test execution. Analytical methods or techniques requiring segregation from the manufacturing areas will be maintained in a central laboratory adjacent to the manufacturing buildings.
The Quality Control Associate III will support to ensure the timely transfer of analytical samples from the WIP laboratories to the central laboratory. These samples include in-process samples, equipment qualification, process validation and other study relevant samples. In addition, the Quality Control Associate I will support the process for retain samples of drug substance and is in charge for sample storage and shipment of stability samples to site-external laboratories. Furthermore, reference standards and qualified materials are ordered and managed for the quality control team and work closely with the global reference group to ensure continuity and stable supply of these.
The Quality organization at the new Solothurn site is envisioned to be supported by team members with diverse backgrounds that are capable of cross functional work to support the high throughput design of the facility. As the site moves through the design phase into operational readiness, Quality staff will be focused on incorporating a new operations strategy into the quality management systems, lab systems and business systems. The operational strategy strongly relies on the incorporation of online real-time monitoring, automation of routine testing wherever possible and integrated information technology systems to bring transparency to routine business operations. As such, experience with electronic batch records and integrated sampling plans would be of advantage.
Associate III, Quality Control
Logistic Management: Work cross functionally to support purchasing, receipt, storage and distribution of test solutions and laboratory reagents for the Solothurn site.
Sample Management: Coordinate cross functional sample pick-up and delivery time with the respective peers from Quality Operation, Manufacturing and Quality Control Chemistry and Microbiology. Including aliquoting of retain samples and management of stability samples and other sample shipments to external/internal testing laboratories.
Support troubleshooting, CLO management and tasks distribution within quality control sample management. Manage small improvement projects within sample management. Manage document update and life cycle management in myCIMS.
Proactively identifies areas for improvement related to quality or process and leads them through completion, can support in internal and external audit proficiently.
Technical degree (5-7 years) or bachelor's degree with industry experience (2-4 years)
2-4 years of experience in pharmaceutical or biotech manufacturing environment and experience within a GMP Quality Control function.
Dual Language preferred with a preference for German and English.
Must have basic knowledge of Microbiology and Chemistry and experience in sample management.
Preferred skills in buffer and solution preparation.
Experience in aseptical working.
Strong organization skills and ability to work autonomously.
Good ability to communicate with all levels of management, peers, contractors and external partners effectively.
Must have experience with typical productivity software (Word, Excel, Outlook, etc.).
Optimally have know-how with TrackWise, LabWare LIMS and Oracle system.