Posted:4 hours ago|
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Work from Office
Full Time
New Chemical Entity- Design & Development (Research & Development)
1. Design & Discover NCE molecules a. Literature search and design route of synthesis b. To help in designing patentable structures of pharmacophore (prodrug design) c. IPR clearance d. Design routes of synthesis e. Synthesis of NCE’s molecules to generate library
2. Synthesis process development and validation a. Development of non-infringing rout of synthesis for lead compound b. Feasibility study c. To finalize the route of synthesis. d. Experiment design according to final route of synthesis e. Development and optimization of synthesis process f. Process Validation
3. Interpretation of analytical data (HPLC, GC, SOR, etc) and prepare analysis specification accordingly a. Analyzing the experiment data obtained from HPLC, GC etc b. Freeze limit of reaction monitoring and impurity in process and intermediate specification on the basis of obtained data c. Preparation of finish good specification according guideline
4. Identification of in process and degradation impurities a. Identification of observed impurity b. Rout cause finding for observed impurity c. Establish data to support rout cause d. Justification for possible impurity
5. Synthesis, characterization and control of impurities a. Draw possible structure of observed impurity b. Design rout for synthesis of impurity c. Synthesis of impurities d. Characterization of impurity e. Decide limit of impurity in specification
6. Identifying, analyzing & separation of isomers a. Identification of possible isomer of compound b. Establish technique for detection and technique for isomer c. Separate isomer and characterize d. Control of isomeric impurity in synthesis process and finish good
7. Scale up the process in pilot plant (Kg level) a. Process development according to plan requirement b. Finalization of batch size c. Equipment suitability d. Monitor and conduct plant trials e. Collection of plant trial data f. Plant report preparation
8. Contribute in discussion and drafting of patent and reply against queries from patent office a. Compile all the experiment details and analytical data b. Discussed with IPR team about novelty and inventive steps c. Generate data if require for patent filing d. Prepare draft of experiment part e. Decide claims
9. General • To maintain the Laboratory ? To help in managing & supervising the conduct of experiment ? Lab Note book writing and required data insertion ? Raw material procurement ? Glassware procurement ? Calibration and maintenance of lab. Instruments ? Documentation (MSDS, Instruments log book,) ? Coordination with Analytical, Purchase, Maintenance and Finance department for lab activity ? Proper labeling of Raw materials, project samples, chemicals and instruments ? Maintenance and implementation of SOPs for various activities ? To create awareness about lab safety ? To improve knowledge of self and colleagues via technical discussion ? Additional activities as when allotted by management
Cadila Pharmaceuticals
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