Mohan Kothawade Email & Phone Number

Aurangabad, Maharashtra, India

✅Leading a team of 12-15 scientists to develop and validate analytical test procedures for US, EU, and WHO market✅Guided a team with respect to analytical regulatory requirements to achieve approval for 2 ANDA projects. ✅Supported with the analytical requirements to achieve successful bio study for 6 ANDA projects✅Developed & Validated an HPLC method for Sodium nitrate and nitrite content for all relevant excipients and formulations to evaluate the risk of… Show more ✅Leading a team of 12-15 scientists to develop and validate analytical test procedures for US, EU, and WHO market✅Guided a team with respect to analytical regulatory requirements to achieve approval for 2 ANDA projects. ✅Supported with the analytical requirements to achieve successful bio study for 6 ANDA projects✅Developed & Validated an HPLC method for Sodium nitrate and nitrite content for all relevant excipients and formulations to evaluate the risk of Nitrosamine✅Developed and Validated suitable methods for Nitrosamine, by GC-MS/MS✅Converted GC methods to an HPLC for the organic impurity to achieve specificity ✅Developed an HPLC method by using GPC for the identification & quantification of functional excipients present in the innovator product, such as HPMC & Ethyl cellulose, etc.✅Identified bio-relevant dissolution method to surrogate bio-equivalence study for ANDA projects✅QSAR study for potential genotoxic impurities by using DEREK NEXUS and LHASA✅Directing a team on Solid Stage Characterization (Polymorphic study & Particle size) of API and Functional excipients by using NMR, XRD, DSC, and TGA techniques. ✅Prepared a comprehensive checklist for DMF review to generate a consolidated response for vendor qualification ✅Providing guidance on pre-formulation and reverse engineering during product development✅Review and approval of technical documents for regulatory submission. ✅Hands-on experience in Analytical QbD (Unscrambler) ✅Guiding QC and in-house team for technical issues, tech-transfer-related challenges✅Working proactively and collaboratively with cross-functional teams such as Formulation, QA, QC, and Project management to achieve project timelines. Show less

Anand,Gujrat

✅Successfully completed the AR&D lab setup as per the US market along with necessary regulatory requirements within a short duration of 2 months.✅Directed the team along with the QA head on renovating the QC laboratory from a takeover pharmaceutical drug product manufacturing facility in Nigeria ✅Guided a team on analytical activities for ANDA projects✅Saved third-party laboratory costs and eliminated the potential gaps in the method validation by performing them… Show more ✅Successfully completed the AR&D lab setup as per the US market along with necessary regulatory requirements within a short duration of 2 months.✅Directed the team along with the QA head on renovating the QC laboratory from a takeover pharmaceutical drug product manufacturing facility in Nigeria ✅Guided a team on analytical activities for ANDA projects✅Saved third-party laboratory costs and eliminated the potential gaps in the method validation by performing them in-house by utilizing existing resources. ✅Supervised the identification of technical gaps within the existing drug products (about 50 in number), devised appropriate corrections, and CAPA, and participated in responding to the regulatory authorities. ✅Guided a team in planning and executing cleaning validations for 20 products in a cut-throat timeline of one month. ✅Developed cleaning process for beta-lactam range of products✅Provided guidance to QC on precautionary measures to avoid common errors during dissolution testing Show less

Pune, Maharashtra, India

✅Method development and validation for drug products by using HPCL, GC, Dissolution and UV spectroscopy✅Completed all compliance-related activities such as SOP trainings, instrument qualification, etc. ✅Achieved critical separation between known and unknown impurity for related substances in a drug product, which had led to several OOS results in the past.✅Responsible for reviewing products development & validation data, working standards, reference standard &… Show more ✅Method development and validation for drug products by using HPCL, GC, Dissolution and UV spectroscopy✅Completed all compliance-related activities such as SOP trainings, instrument qualification, etc. ✅Achieved critical separation between known and unknown impurity for related substances in a drug product, which had led to several OOS results in the past.✅Responsible for reviewing products development & validation data, working standards, reference standard & impurities management, calibration record, stability study record, and laboratory notebooks review.✅Performed key role as a safety officer for ADL to manage fire extinguisher equipment, safety kit, safety awareness training, destruction of all expired & handling of toxic chemicals. ✅Winner in safety competition arranged during safety week for more than 5 consecutive years ✅Two times recipient of the individual high-performance award due to surpassing the expectation. Show less

Ahmedabad, Gujarat, India

✅Method development and validation for drug products by using HPCL, GC, Dissolution, and UV spectroscopy✅Analysis of stability samples, drug substances, and drug products for various tests including assay, related substances, dissolution, residual solvents✅Calibration of common lab instruments such as HPLC, GC, Dissolution, UV.

Vadodara, Gujarat, India

✅New Lab set-up was successfully completed within 3 months including area qualification and qualification of all common lab equipments, and instruments✅Developed high throughput single method for multiple residual solvents by GC-HS

Mumbai, Maharashtra, India

✅Successfully completed the installation and imparted hands-on experience to the QC team ✅Method development for residual solvents by using GC✅Completed method transfers for GC methods to QC lab✅Conducted stability study, and routine development sample analysis by using HPLC, GC, and Dissolution.

Daund, Maharashtra, India

✅Learned about GLP/GMP activities & performed a supporting role in various audits and direct interaction with USFDA auditors at a very junior level✅Routine analysis for Finished products such as soft gels, suppositories, tablets & capsules by using HPLC, Dissolution, GC

M.Sc., Analytical Chemistry

M.Sc.Analytical Chemistry, Chemistry