Jitendra Nalawade
Technical Lead @Almac Group
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WORK HISTORY
Technical Lead @Almac Group
Small molecule synthesis, solid/solution phase peptide synthesis of phase I, phase II, late phase molecules. Peptide conjugation. Purification involving preparative columns, tangential flow filtration(TFF), cGMP manufacturing.
EDUCATION
Savitribai Phule Pune University
Doctor of Philosophy - PhD, Organic Chemistry
Savitribai Phule Pune University
M.Sc.Drug Chemistry
Savitribai Phule Pune University
BSc, Chemistry
National Academy of Legal Studies & Research (NALSAR) University Hyderabad
P.G.Diploma in Intellectual Property Rights( Patent Law)
ABOUT JITENDRA NALAWADE
Extensive experience of execution and management of API/intermediate process development of small molecules and peptides. Technology transfer to production by following cGMP guidelines. PhD in Organic Chemistry from Savitribai Phule Pune University,India.MSc in Drug chemistry from Savitribai Phule Pune University Post Graduate Diploma in Patent Law from NALSAR University of Law Hyderabad,India Highlights of My work experience: My current job is to lead a project which involves synthesis of small molecules and peptides for BIG Pharma companies and spinouts.Failure mode and effects analysis (FMEA) study using DOE through statastical software JMP. Aiming development of robust, eco efficient, operation friendly, safe process through detail literature search & following GMP norms.Experience of TEVA global Impurity Lab set up & management.Polymorph, enzymatic study where ever required.Preparing Process development, Safety, Genotoxic reports.Also to protect the innovation through filing patent of process, Infringement analysis,Patent drafting.Actively involved in various managerial, scientific, team building and Safety trainings.Wide experience of Organic Synthesis of APIs involving complex chemistry, Asymmetric synthesis, troubleshooting during scale up, quality issues.Support for DMF filings.Successful transfer of technologies to multiple sites across India.Experience of Third party manufacturing. Dealing with Vendors, Suppliers, cross functional teams.CRO Experience: Extensive experience of Contract Research which involved milligram to gram scale organic Synthesis of molecules which were drug discovery projects of Pharma giants like Roche, Elli-Lily, and Amgen etc. Well versed with Organic Synthesis, organometallic chemistry, amide coupling, metal reductions, and reductive amination using advanced reagents.Good hands on column chromatography, crystallization, combiflash, Chromatotrone, Lyophilizer, preparative HPLC.Knowledge of Flow reactions.
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