Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.
Basic Major Activities (Describe main activities)
1.Actively participate in teams, projects, networks and/or platforms. Fulfill all related tasks and responsibilities related to own discipline. (I)
2.Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s). (I)
3.Design, plan, perform and monitor all assigned activities. (I)
4.Meet quality, quantity and timelines in all assigned projects, networks and/or plat-forms. (I)
5.Actively participate in budget forecast, grant preparation and tracking of invoices. Demonstrate cost awareness in all assigned projects and/or networks. (K)
6.Advise team members and work according to appropriate SOP s, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines. (N)
7.Interpret results, evaluate data, draw relevant conclusions, write reports. (I)
8.Contribute to risk analyses and/or peer review and process challenge meetings. (M)
9.Generate scientific documents to hand over to internal and/or external partners (TechOps, authorities, external companies) (I)
10.actively support generation of international registration documents. Interact with authorities where appropriate. (U)
11.Interact/collaborate with Research and/or other functions in Development to facili-tate transfer of knowledge and deliveries of DS and/or DP. (I)
12.Actively contribute to team goals. (I)
13.Contribute to evaluation of new scientific technologies/equipment and prepare CAR and USR if applicable. (I)
14.support the journey towards a multi-skilled, highly innovative and motivated workforce operating in a self-directed team set-up. Support cultural evolution and change management. (Leadership)
15.Coach/lead team members: support objectives setting, performance evaluations and development planning discussions with team members where appropriate. Participate in recruiting process if applicable. (Leadership)
16.Ensure all own activities are aligned with overall drug development process. (B)
17.Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guide-lines. (N)
18.Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives (I)
S&T Specific Activities (Describe main activities)
1.Design, plan and perform scientific experiments. Provide efficient and robust pro-cesses for the manufacture and/or analysis of intermediates, drug substance and drug product as per own discipline. (I)
2.Report and present scientific/technical results internally and contribute to publica-tions, presentations and patents. (I)
3.Utilize complex tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs. (I)
4.Maintain infrastructure/equipment and required investments. (I)
Project Management Specific Activities (Describe main activities) Project Leader
1.Lead, represent, manage and support departmental project team for selected project(s) and/or local network(s). Support teams with strong quality awareness, strategic input, scientific and technical expertise. Foster strong team spirit and promote knowledge exchange within and between teams. Set objectives and priorities for the team(s). (K)
2.Understand and actively manage the interactions of project and/or local network related activities between own department and other departments inside and out-side of TRD (e.g. NIBR, TechOps, 3rd party, etc.). Act as ambassador for xHAD within TRD. (K)
3.Formulate and implement a sound departmental project strategy incl. contingency planning and risk assessments as appropriate (in line with overall project strategy elaborated by the TRD project team), involving departmental/functional experts. (K)
4.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 member(s). (M)
5.Ensure suitable composition of the departmental teams to support assigned pro-ject(s) and/or local network(s) in cooperation with line function management.(K)
6.Assess, consolidate and negotiate on an on-going basis within department all inter-nal and external resource needs as well as timelines for assigned project(s) and/or local network(s). Ensure department budget and resource adherence for the as-signed project(s) and/or local network(s), including KPIs and xHAD metrics. Ensure timely availability of agreed deliverables (e.g. goods, processes, analytical methods, documentation). (K)
7.Facilitate the setting process of technical as well as values & behaviors objectives for the project and/or local network team(s). Discuss and finalize team objectives with the Unit Head. Communicate final objectives to the team. Assess technical goal achievement of the team based on assessments from the team, the Project Leader and the Unit Head in the context of xHAD performance cross calibration . Give strong input into the peer performance review of team members regarding values and behaviors together with the xDU Manager. (K)
Device Development Specific Activities Engineer 1
1.Design, plan, perform and contribute to project related to scientific/technical engineering activities and design, plan and perform scientific experiments. (I)
2.Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products (e.g. tolerance analysis, risk analysis). (I)
3.Coordinate with team members assigned to multiple or complex device development activities. (I)
4.Ensure appropriate planning of workload and resources internally and externally, controlling costs and timescale of the respective project tasks. (K)
5.Report and present scientific/technical results internally and contribute to publications, presentations and patents. (I)
6.Support DRA to prepare select Medical Device/Combination Product pre-registration documents and provides input to answer health authority questions. (U)
7.Support all, and leads select, activities related to the development of the assigned device projects. (I)
8.Support the evaluation of external device collaborations. (I)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: Technician with continuing education (EU) or BS/MS or equivalent
Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
Experience/Professional requirement (for recruitment purpose):
1.Excellent knowledge of laboratory and/or
2.Proficient in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs.
3.Good knowledge of software and computer tools.
4.Profound literature search skills.
5.Ability to work in and/or lead teams.
6.Strong leadership skills.
7.Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
8.Very good communication skills. Good presentation skills and scientific/technical writing skills. Advanced coaching skills.
9.May require up to 15% travel
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.