Novartis - Fellow

Job Description

1. Actively participate in teams, projects and, networks. Fulfill all related tasks and responsibilities.

2. Plan, perform, monitor, interpret and document DS/DP related analytical activities including release/stability testing, method development/validation etc.

3. Provide efficient and robust processes for the analysis of DS/DP

4. Interact/collaborate within TRD functions to facilitate transfer of knowledge of DS/DP

5. Ensure department budget and resource adherence for the assigned project(s) and/or network(s), including KPIs and metrics. Ensure quantity, quality, timely availability of agreed deliverables (e.g. processes, analytical methods, documentation).

6. Support and assign associates in specific projects and/or networks. Coach on target dates and priorities.

7. Proactively participate in budget forecast, grant preparation and tracking of invoices. Ensure costs and cost awareness in all assigned projects and/or networks.

8. Advise team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines.

9. Contribute to optimization of scientific/technical activities in assigned projects and networks. Contribute to optimization of processes within PHAD India.

10. Contribute to risk analyses and/or peer review and process challenge meetings.

11. Generate and select most appropriate scientific documents to hand over to internal and/or external partners and proactively support generation of international registration documents. Interact with authorities where appropriate.

12. Actively support TRD as a technical expert on audits and/or inspections. Proactively contribute to setting, updating and monitoring of team goals. Translate team goals into daily work.

13. Coach/lead team members: support objectives setting, performance evaluations, development planning discussions and ensure all related tasks (objectives entered, help to identify needs for training courses and development of new skills, etc.) are performed appropriately. Participate in recruiting process.

14. Report and present scientific/technical results internally and publish/present externally in scientific journals and conferences including patents.

15. Identify and drive implementation of new scientific technologies and approaches.

16. Ensure maintenance of infrastructure/equipment and required investments.

Minimum Requirements

1. Successfully demonstrated several years Post MSC/MPHARM with min 12+ Yrs and with PHD 10+Yrs of relevant experience

2. Expert in analytical methods development including method development for genotoxic impurities and degradation products

3. Expert in the use of analytical instrumentation including HPLC, GC, LC-MS, DR, titirmeters, spec-troscopy and/or cascade impactor (for inhalation testing). Advanced computer skills in LIMS, chromatography data acquisition systems and MS Office software.

4. Thorough understanding of development activities and processes in pharmaceutical industry

5. Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.

6. Proven leadership skills. Must be able to mentor junior associates

7. Strong knowledge of cGMP, ISEC and HSE requirements

8. Excellent communication, presentation skills and scientific/technical writing skills. Advanced coaching skills.

9. Candidate must be able to quickly adapt to changing project needs, assignments and environments. Good project management, time management, and decision making skills are also expected