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-ofâthe-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.
CSL Plasma operates one of the worldâs largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.
Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/.
Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
 To learn more visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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