Senior Engineer (Drug Delivery Lead)

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.

• 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.