ANKIT SINGH
About Candidate
Topic: Development and pre-clinical characterization of two anti-VEGF Fab molecules for the treatment of DR and AMD.
Achievement: Successfully received C3/C4 and C5/C6 approval from RCGM for novel biologics.
Research and Development Role:
1. Spearheading research activities and performing biochemical and biophysical analysis of Fab biomolecules and resolving procedural problems for timely completion of research objectives.
2. Developing and fixing the procedures of QELISA, Affinity ELISA, BET, SEC-HPLC, RP-HPLC, Carbenicillin Detection, Protein L leakage, HCP, HCDNA, SPR, LCMS, IC50 and PK/PD studies etc.
3. Carrying out regular preclinical Stability, Efficacy, Contaminants, and characterization studies for two Fab molecules and reviewing of ongoing research trends time to time
4. Accountable for quantitative and qualitative assessments as well as provide technical support to monitor the product development.
Role in Quality Assurance/ Quality Control:
1. Reviewing the operational practices, identifying the areas of obstruction or quality failures, and advising on system and process changes for qualitative improvement.
2. Planning and execution of complete quality control functions as per preset ICH guidelines.
3. Coordinating with QA/ QC personnel for implementation of current or revised standard testing procedures and specifications for new products.
4. Preparing documents of developed analytical SOP, OOS and OOT specifications for the use of QC personnel.
5. Imparting training for staff and workers to ensure safe work practices.
Role in Regulatory Affairs: Preparing SOP, MDR, MVR, TTD, BAR, ROA, C3, C5, cGMP, GLP, eCTD documentation for IND submission.
Location
Education
Development of oral vaccine against rabies (Biotechnology).
Biochemistry (Biophysical characterization of wild and mutant humane MTHFR enzyme from E. coli.)
Chemistry, Zoology and Botany.
Work & Experience
Topic: Development and pre-clinical characterization of two anti-VEGF Fab molecules for the treatment of DR and AMD. Achievement: Successfully received C3/C4 and C5/C6 approval from RCGM for novel biologics. Research and Development Role: 1. Spearheading research activities and performing biochemical and biophysical analysis of Fab biomolecules and resolving procedural problems for timely completion of research objectives. 2. Developing and fixing the procedures of QELISA, Affinity ELISA, BET, SEC-HPLC, RP-HPLC, Carbenicillin Detection, Protein L leakage, HCP, HCDNA, SPR, LCMS, IC50 and PK/PD studies etc. 3. Carrying out regular preclinical Stability, Efficacy, Contaminants, and characterization studies for two Fab molecules and reviewing of ongoing research trends time to time 4. Accountable for quantitative and qualitative assessments as well as provide technical support to monitor the product development. Role in Quality Assurance/ Quality Control: 1. Reviewing the operational practices, identifying the areas of obstruction or quality failures, and advising on system and process changes for qualitative improvement. 2. Planning and execution of complete quality control functions as per preset ICH guidelines. 3. Coordinating with QA/ QC personnel for implementation of current or revised standard testing procedures and specifications for new products. 4. Preparing documents of developed analytical SOP, OOS and OOT specifications for the use of QC personnel. 5. Imparting training for staff and workers to ensure safe work practices. Role in Regulatory Affairs: Preparing SOP, MDR, MVR, TTD, BAR, ROA, C3, C5, cGMP, GLP, eCTD documentation for IND submission.
Development of CLCuV viral resistance through CRISPR-Cas9 based genome editing
Comparative proteomic analysis of differentially expressed proteins for stress tolerance.
Identification and characterization of stress tolerant genes.
Development of oral vaccine against rabies.
