The main responsibility of the Senior Manager, Quality Control Biochemistry is to lead activities associated with establishing the testing capabilities of the drug substance manufactured at Biogen’s new large scale manufacturing facility in Solothurn, Switzerland facility. The Biochemistry senior manager will be accountable for the instrumentation associated with all testing within their areas of responsibilities, including assurance of proper IQ /OQ / PQ in alignment with Biogen’s Global standards. Testing at the site is anticipated to include analyses such as icIEF, SEC, SoloVPE, CE-SDS, LC/MS, Binding Analyses along with traditional compendia based analyses for pH, Appearance and Osmolality. All instruments will be interfaced to the LIMS (LABWARE) system employing full electronic lab notebook enabling all data are managed electronically with no manual data transfers.
The QC Biochemistry Senior Manager will have an initial responsibility to ensure the labs, the equipment and the test methods are ready for routine operation. To accomplish this task the QC senior manager will have to work closely with the capital project team for laboratory realization and equipment purchase and with the Global Quality team to ensure the analytical methods are transferred and made ready for execution in a compliant manner. The Solothurn facility design includes working in-process (WIP) labs specific to process unit operations embedded within the manufacturing environment. It will be the expectation that analytical methods executed in these WIP laboratories are owned by the Quality department; therefore the Biochemistry senior manager will have oversight and accountability for these equipment and assays. The planned future state of the facility in Solothurn includes the use of multivariate models to predict product quality attributes and drive batch release decisions (consistency models). The Biochemistry senior manager will have oversight for the daily monitoring and response approaches for model anomalies and prioritization of model updates for the site.
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 depends heavily 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 are not requirements for the position, but would benefit the organization.
1. Prepare the chemistry / biochemistry labs for routine operations from construction through process validation/PPQ runs. Hire, lead and manage supporting lab staff.
2. Support method transfer activities from existing Biogen sites to Solothurn. Ensure the site is prepared for routine testing and operations. Manage day to day operations within the Central and WIP labs.
3. Author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.) requiring the ability to grasp and apply regulatory and compliance knowledge from multiple markets/agencies
4. Drive activities at the Solothurn site to adhere to the construction or operational schedule
5. Support execution of analytical capability strategy. Work cross functionally to support purchasing, receipt, IQ/OQ/PQ of analytical equipment for the Solothurn site.
6. Serve as a Quality team member representative during construction to address schedule and tactical aspects of project execution.