As part of this group, you design, plan and/or perform scientific/technical studies. By bridging the analytical science to the clinical performance you will drive the transformation of our molecules into medicines that improve and extend patient s lives.
The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD).
Job Description
Major accountabilities:
1. Provide analytical and technical support to PHAD/project team at various stages of product development (eg. CSF, FMI and LCM) 2. Design and author analytical documents (e.g., Analytical methods, Stability protocols/reports, Excipient compatibility (EC) protocol/reports; APS protocols/reports, etc.). 3. Support Analytical project leader for setting analytical development strategy. 4. Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team. 5. Responsible for project related sample handling (e.g., sampling plans, issuance, storage, distribution, reconciliation/destruction of the samples) . 6. Support planning for assigned project activities. Accountable to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned project activities. 7. Provide requests for lab activities to the associates and stakeholders. 8. Manage project activities including logistics at third parties and external testing laboratories. 9. 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). 10. Single point of contact for PHAD/project team and other stakeholders (e.g, BioPharm, Material science and CPP, etc.) for project execution activities. 11. Support internal and external audits and ensure no critical findings within the assigned projects. 12. Actively contribute to team goals. 13. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines. 14. Subway: Author (EC/APS protocol and reports), review of test methods and compatibility study plan. 15. ESOPS: Read SOP access and Review of SOPs.
Minimum Requirements:
Desirable knowledge of site language. Up to 10 years (for M.Pharm./M.Sc.) & minimum of 4 years (for Ph.D.) of relevant experience in testing of Solid oral dosage form.
Good presentation skills and scientific/technical writing skills.
Good communication skills
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Skills:
Dissolution method development
Titration
Stability studies
LC method development
DVS
Forced degradation
Excipient compatibility
Skills Desired
Environment, Experiments Design, Health And Safety (Ehs), Laboratory Instrumentation, Manufacturing Processes, Materials Science, Process Simulation, Standard Operating Procedure (SOP), Technical Writing, Waterfall Model