Require Bio Analyst at Novartis

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Bio Analyst

Job Description
1. Provide bioanalytical expertise to the clinical development team in country or across the clinical development network in Sandoz small molecule
2. Contribute to the activities of the bioanalytical expert network in Sandoz small molecule (process harmonization, knowledge sharing etc.)
3. Check the availability of analytical method in CROs, contribute knowledge to analytical method development and validation as needed 4. Ensure appropriate CRO selection for conduct of the bioanalytical part of BE studies in close alignment with the Clinical Research Manager
5. Closely collaborate with the study responsible Clinical Research Manager / Clinical Scientist to enable an efficient and on time study conduct. Work close with the study team to ensure that all the logistics around bioanalytics is set up (freezer, shipment, sample tubes etc.)
6. Check the availability of analytical method in CROs, contribute knowledge to analytical method development if needed
7. Review bioanalytical validation reports and ensure that the assay is set up in compliance with regulatory requirements for the region(s) of planned submission 8. Review study protocol with focus on bioanalytics (analytical range, anticoagulant, logistics for bioanalytical samples etc.)
9. Review bioanalytical protocol and ensure that all necessary requirements are covered 10. Off-site analytical monitoring (review of chromatograms, results, repeats etc.)
11. On-site analytical monitoring in country and international
12. Review analytical part of BE study report and ensure that analyses is conducted in accordance with regulatory requirements (i.e handling of outliers, high intra-subject variability etc.) 13. Contribute to preparation of relevant parts of registration documents and interactions with health authorities in context of clinical bioanalytics (e.g. scientific advices, deficiencies letters)
14. Contribute to development of procedures (SOPs) for clinical bioanalytics
15. Ensure conduct of bioanalytical work in compliance with regulatory requirements and internal processes
16. Contribute as requested to budget and resource planning for bioanalytical work
17. Proactive knowledge sharing within department, SDC and Sandoz
18. Active participation in project teams
19. Contribute as agreed with line manager to other clinical related tasks like clinical due diligence

Candidate Profile
M.Sc or PhD in Life Sciences Fluent in English (oral and written)
1. Minimum 3 years experience in bioanalytics
2. Hands on work experience in laboratory
3. Knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials.

Additional Information
Experience : 3 years
Qualification : M.Sc, Ph.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th June, 2019