Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.
Candidate having experience of Bio-similar product manufacturing. Large scale bioreactor, Continuous centrifuge
Trouble shooting, risk assessment, root cause analysis.
The Clinical Data Management Associate is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements.
Expertise in different types of purification techniques. Sound knowledge of different column chemistry used in HPLC. Responsible for troubleshooting of instruments and their calibration
M.Sc./ M.Tech./ M.Pharm./ B.Tech. or equivalent in Biotechnology and allied areas; Research project entitled Targeting Autophagy and Microtubule Dynamics for Next- Generation Cancer and Neurovegetative Disease Treatment funded by Gujarat State Biotechnology Mission, Govt. of Gujarat.
B.Pharm / M.Pharm; Compile, review and timely submission of Deficiencies responses as received from Health Canada. Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines.