The Role:
In this role (hybrid working model with a mandatory three day per week office presence) you will be responsible for bringing new Drug Delivery Systems through the development process. You will have considerable cross-functional interaction, that includes Quality Assurance, Regulatory Affairs, Packaging, CMC, Clinical and Commercial functions. This role reports to the Section Head of Design Assurance in Bern (Switzerland) that is integrated into the global Drug Delivery System function within CSL. The Drug Delivery System function develops combination products and medical devices for the CSL portfolio of drug products.
Specific Accountabilities, Responsibilities and Activities:
* Responsible for the planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products.
* Execution of projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices.
* Collaborate with global internal cross-functional expert teams. Provide leadership to ensure the coordination of activities and information between the functions and with external partners.
* Application of expertise in Design Controls and Risk Management (ISO 13485, ISO 14971, and 21 CFR 820), EU MDR requirements, compilation and maintenance of Design History Files, design verification and validation, and clinical trial/commercial manufacture support.
* Provide leadership to Project Team to deliver submission-ready packages for Notified Bodies and regulators, as well as RFI responses.
* Utilise engineering and analysis tools to ensure robust designs and understand device limitations, (e.g., root cause analysis, tolerance analysis, probabilistic design).
Qualification & Experience:
* University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field.
* Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment.
* Ideally a background in development of combination products for respiratory drug delivery.
* Ideally experience in project leadership in a matrix organization.
* Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills (English).
* Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies.