Quality Control Site Head

JOB PURPOSE: The role of the Quality Control Site Head of the new Large Scale Manufacturing facility in Solothurn, Switzerland is to ensure that analytical capabilities (chemistry, microbiological, EM/UM, safety testing through DNA-technologies (adventitious agents, MMV and mycoplasma)) are designed to accommodate the intended manufacturing support and fulfilling regulatory requirements as the project progresses from construction through to licensing. The extent of the analytical capability includes but is not limited to leading balanced laboratory design between in-house and contract laboratories. The scope of analytical portfolio encompass: production components, raw materials, in-process testing (routine and non-routine) as well as release testing with the widest possible use of Real-Time Release Testing through multivariate models. The establishment of scalable and efficient QC systems as well processes to enable seamless supply of raw materials are of pivotal importance to this role and the facility.

It is of key importance to this role to fully understand and benefit from possibilities in current Biogen quality systems to develop, expand, simplify and innovate quality control processes while optimizing compliance. The role has the responsibility to familiarize themselves with, build on and continue to ensure alignment of the next generation manufacturing philosophy and operating principles.

MAIN ACCOUNTABILITIES

• Fulfill role as Quality control lead to ensure raw material paradigm is implemented and maintained at the Solothurn facility. he responsibility of the QC lead will be to coordinate with all stakeholders (e.g. procurement, external auditing, Manufacturing Science) to ensure fast ID (NIR/RAMAN/FT-IR) methods are implemented to highest possible extent and that sourcing of the materials are considered in a way to minimize incoming lots as well as full potential of auditing of vendors are benefited from. Ultimate goal will be to maximize quality of raw materials with thorough considering for value adding QC steps.
• Fulfill role as Quality Control lead during: a) design (understand current proposed analytical control strategy and design for flexibility) b) construction c) procurement of analytical instruments (ensure full utilization of vendor time in qualifications) d) facility certification (ensure analytical capability is in place in timely manner for EM/UM) and validation (ensure analytical capabilities are in place in a timely manner). All instruments to support analytical capability of manufacturing support shall meet Biogen quality standards. Full support of laboratory operations following validation and regulatory approval to include timely testing of raw materials, in process, environmental and release samples.
• Develop testing paradigm to ensure that the full benefit of Advanced Process Control (APC) and iQC (Labware LIMS improvement) project charters are fully implemented. It is pivotal that all instruments used at the Solothurn facility will have full connectivity to LIMS. Additionally an assessment and project plan for QC procedures that need to be issued or updated should be generated aligned with project schedule)
• With the combined knowledge of new facility design of the Solothurn plant and analytical control strategy, identify areas that may differ from Biogen current way of operating and ensure that areas of risk are identified and appropriate quality risk assessments will be executed. Including, but not limited to a regulatory testing strategy should be generated to accommodate Biogen priority markets (factors as in-country testing, traditional release testing should be incorporated).
• Development of skills and behaviors that align with the overall goals of the Solothurn project and the vision and mission of Global Quality as well as development towards personal career – to be able to map sample workflows – and innovate – so he needs to dig in to iQC project and ensure Solothurn requirements are part of design expectations. including training of operations etc.
• Must have demonstrated capability for managing all aspects of laboratory design, daily operations and documentation.
• A minimum of 10 years related experience and/or training .
• Thorough understanding of all steps of a start-up of a drug substance

The role of the Quality Control Site Head of the new Large Scale Manufacturing facility in Solothurn, Switzerland is to ensure that analytical capabilities (chemistry, microbiological, EM/UM, safety testing through DNA-technologies (adventitious agents, MMV and mycoplasma)) are designed to accommodate the intended manufacturing support and fulfilling regulatory requirements as the project progresses from construction through to licensing.