Design, plan, interpret and report results of analytical scientific experiments for the preparation and timely delivery of API and drug products (DP), processes and procedures. Lead and manage overall analytical project strategy globally, support analytical network activities, support/coach analytical team members globally, participate in sub-teams and contribute to overall TRD strategies and goals.
Basic Major Activities (Describe main activities)
1. Accountable in PHAD sub-team to drive overall analytical project strategy and for major analytical activities for both API and DP. Design, plan and monitor analytical activities (such as i.e. DS/DP method development and validation, DS/DP stability, DS/DP release and transfer activities) across all analytical sites. Provide efficient and robust analytical methods for the analysis of intermediates, drug substance and drug product. Accountable for specification setting (I)
2. Lead, represent, manage and support analytical project team for selected project(s). Support analytical project teams with strong quality awareness, strategic input, scientific and technical expertise. Foster strong team spirit and promote knowledge exchange within and between teams. Set analytical objectives and priorities for the team(s) (K)
3. Actively participate in PHAD sub-team meeting. Fulfill all related tasks and responsi-bilities related to own discipline. (I)
4. Actively manage the interactions of project related analytical activities across TRD sites eg India or China, outside of TRD e.g. ChemOps, PharmOps and outside of No-vartis at third party. Accountable for analytical outsourcing strategy and external collaboration.
5. Interact/collaborate with other functions and department to facilitate transfer of knowledge and deliveries of DS and/or DP. (I)
6. Contribute to risk assessment, peer review and process challenge meetings. Review and finalize SSS/QbD documents (M)
7. Actively support generation of registration documents. Review of CMC modules. In-teract with authorities where appropriate, answer Health Authority requests. (U)
8. Interpret results, evaluate data and draw relevant conclusions. Reviewer of key ana-lytical documents and reports. (I)
9. Report and present scientific/technical results internally and contribute to publica-tions, presentations and patents
10. Meet quality, quantity and timelines in all assigned projects (n)
11. Advise/coach team members and work according to appropriate SOP s, GLP, GMP, QM, HSE, ISEC and Novartis guidelines. (N)
12. Proactively communicate overall analytical 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)
13. Actively participate in budget forecast, grant preparation and tracking of invoices. Demonstrate cost awareness in all assigned projects. (K)
14. Contribute to evaluation of new scientific technologies/equipment
15. Ensure analytical strategy and all analytical activities are aligned with overall drug development process.(B)
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: BS/MS or equivalent
Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
Good knowledge of English (oral and written). Desirable knowledge of site language.
1. Excellent knowledge of analytical techniques, laboratory and/or technical tools.
2. Proficient in utilization of special analytical and documentation tools eg Chromeleon, Glims and TEDI
3. Good knowledge of software and computer tools.
4. Profound literature search skills.
5. Strong leadership skills including the ability to work in and/or lead teams across different sites
6. Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
7. Very good communication skills. Good presenta-tion skills and scientific/technical writing skills. Advanced coaching skills.
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