| || 216847BR |
| || Device Development Project Leader – Portfolio (m/f) |
| || Novartis Technical Operations |
| || NTO BTDM |
| || Austria |
| || Schaftenau |
| || Sandoz GmbH |
| || Research & Development |
| || Full Time |
| || Regular |
| || • Lead, represent and manage complex and large cross-functional device development projects or platform project teams.
• Accountable for project definition, establish project team, delivery and communication from development up until transfer.
• Formulate and implement a scientifically sound and business driven project strategy incl. risk assessment and contingency planning.
• Assess, consolidate and negotiate on an on-going basis all internal and external resource needs as well as timelines and budget
• Representative for all device project related activities during health authority inspections and interactions
• Monitor, support and challenge technical development as well as test and verification work
• Accountable for establishing a high quality Design History File (DHF). Lead and document design reviews / gap analysis and create reports
• Support and lead cross functional project teams in the development, review and submission of regulatory dossiers
• Support and coordinate the manufacturing of devices and combination products for clinical trials and supporting the production scale up.
• Ensure compliance with Design Control and CMC requirements for FDA combination products regulations and applicable ISO requirements for U.S. and foreign marketed products.
| || • Education: University degree in a scientific or technical discipline
• Languages: English (fluent) / German (basics) beneficial
• Experience: Relevant practical experience of at least 10 years in the development and registration (up to commercialization) of drug delivery devices, broad and in depth technical knowledge of parenteral drug delivery devices. Thorough and proven knowledge of GMP and international device regulations.
• Personal skills: Proven project management skills, strong communicator and problem-solving skills, ability to work in matrix environment and lead interdisciplinary, cross-cultural teams
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 54.469,10 euros.
Contact: Cornelia Walch, Staffing Manager