Position purpose :
Lead and manage a delivery system including all technical development activities for the pre-filled syringes & needle safety device.
Apply expertise to address complex design, development, operational issues and actively lead the device technical development in decision making, strategies and goals by participating in cross-
functional teams. Lead strategic activities, co-ordinate interdisciplinary projects and teams. Develop long term strategies on technologies processes and medical devices and primary packaging related matters.
1.Develop strategies for planning and performing technical activities on projects in development.
2.Coordinate the packaging technology team members assigned to multiple or complex packaging activities.
3.Maintain knowledge in the areas of materials (glass, polymer, rubber, silicone / lubricant, sterile barrier system, adhesive).
Manufacturing (injection moulding, glass converting, rubber moulding, assembly, fill&finish, transport validation).
4.Develop packaging concepts to support early phase development.
5.Conduct feasibility assessments on new technology / packaging concepts (incl. Due Diligence).
6.Conduct design for manufacture assessments.
7.Conduct tolerance stack analyses.
8.Maintain technical drawings and models.
9.Contribute to risk analyses.
10.Lead the establishment and implementation of packaging technology development best practice.
11.Lead the establishment of standard operating procedures, work procedures, document templates and general guidance for the application of HFE in device development.
12.Coordinate the dissemination of knowledge and awareness of novel device technology within the wider organization and contribute to publications, presentations and patents.
13.Collaborate with cross-divisional stakeholders to establish packaging technology strategy.
14.Support DRA to prepare Medical Device / Combination Product pre-registration documents and provide input to answer health authority questions.
15.Lead the combination product documentation required for registration.
16.Coordinate packaging technology input to internal and external audits and inspections.
Min. BS / MS, Ph.D. or equivalent desirable
Good knowledge of English (oral and written).
Desirable knowledge of site language
Successfully demonstrated several years (mini-mum 8 years) experience in medical device or pharma industry or equivalent.
Recognized expertise in a specific area and broader scientific as well as strategic background.
Proven track record of creativity, problem solving and productivity in projects.
Good overview of current trends and upcoming techniques for current and future applications.
Thorough understanding of device development and commercialization processes in the industry and deep knowledge of related basic regulations
Demonstrated successful experience with working in interdisciplinary, cross-cultural teams and / or matrix environment and influencing / leading team members.
Excellent leadership skills.
Thorough knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
Excellent communication / presentation skills and scientific / technical writing skills.
Advanced coaching and mentoring skills.
May require up to 15% travel.