176 days ago on sjobs.brassring.com

Device Development Project Leader

Novartis Pharma Schweiz AG

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Device Development Project Leader

Job ID 214289BR Position Title Device Development Project Leader Division Novartis Technical Operations Business Unit NTO BTDM Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Leads, represents and supports cross-functional device development projects in line with Biologics Technical Development & Manufacturing (BTDM) Device Portfolio needs. In particular leads projects with several device presentations.

1. Leads, represents and manages cross-functional device development project teams setting objectives and priorities, and supports teams with strong quality awareness, scientific and technical expertise.

2. Accountable for project definition, establish project team, delivery and communication from development up until transfer.

3. Formulate and implement a scientifically sound Device Development & Commercialization (DD&C) project strategy incl. risk assessment and contingency planning as appropriate and in line with overall Chemistry Manufacturing Controls (CMC) team project strategy, involving departmental and/or functional experts.

4. Ensure suitable composition of the Device Development Project team to support assigned project(s), and/or existing platform projects(s) in cooperation with line function management and Device Portfolio Group Head.

5. Assess and consolidate on an on-going basis within DD&C all internal and external resource needs as well as timelines for assigned project.

6. Represent DD&C in cross-functional CMC sub-teams, acting as an ambassador for DD&C within BTDM and external partners for the assigned projects.

7. Understand and proactively manage the interactions of project related activities between DD&C and other departments inside and outside of Novartis (e.g. 3rd parties).

8. Maintains awareness of current regulatory requirements, ensuring compliance with current regulation and internal process requirements.

9. DD&C representative for all device project related activities during health authority inspections and interactions.

10. Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members.

11. Ensure project objectives are in alignment with CMC team and DD&C objectives, providing feedback and input to peer performance review of team members regarding performance, values and behaviors.

12. Lead DD&C process improvements.
Minimum requirements Relevant degree in Engineering or Life Science (Bachelor, Master)

Fluency in English Proficiency in German and/or French advantageous

• 5+ years’ experience in managing the development and registration (up to commercialization) of drug delivery devices.

• Technical knowledge of parenteral drug delivery devices.

• Knowledge of Good Manufacturing Practice (GMP) and international device regulations (including Quality System Regulations (QSR) e.g. 21CFR820 / MDD and ISO standards)

• Track record of innovation, creativity, problem solving and productivity in projects.

• Good project management skills with the ability to prioritize and manage a complex set of projects, delivering objectives on time and within budget.

• Good understanding of cross-functional device development processes.

• Leadership skills, esp. in a matrix setting.

• Ability to communicate and collaborate effectively in a highly international and diverse setting.