Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.
Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
MSc. with 1st Class in Genetics,Human Genetics, Life Sciences, Biochemistry from recognized university and suitability bases on CSIR, UGC, ICMR, DBT, etc.
Method validation, verification and transfer to Quality control lab for OSD and PFOS formulations. Development, optimization and validation of analytical methods to support OSD formulation ANDA.
M.Pharm / MSc. in Analytical Chemistry / Organic Chemistry; Execute the Isolation projects. Carry out the isolation, purification of known and unknown impurities, compounds by preparative HPLC and characterization of molecules using various analytical techniques. Involve in project acceptance.
Senior scientist-II will work on isolation, purification of known and unknown impurities/compounds by preparative HPLC and characterization of molecules using various analytical technique and Analytical Method Development for in process samples received from synthetic Lab.
He, she will be responsible for providing Therapeutic Area workstream leads with administrative support on pre-defined projects. The Project Manager will set and develop the operational aspects of the project, develop, and monitor timelines, milestones and project metrics and is responsible for managing the projects from an operational perspective from the development and initiation phases through implementation and completion within scope provided by Medical Directors who remains responsible and accountable for the project content.
Doctoral Degree in Science, Engineering, Technology, Pharma, MD, MS from a recognized University or equivalent. CSIR-Centre for Cellular and Molecular Biology, Hyderabad is a premier Research Institute under the aegis of Council of Scientific & Industrial Research, an autonomous body under the Ministry of Science & Technology, Government of India.
Bacterial Endotoxin testing for routine samples, and regular water testing. Analytical method validations related to the BET, MLT, and Bioburden testing. Plate reading for different microbiological analysis. Daily Observations of the sterility test canisters, tubes.