Sudhakar Reddy.

About Sudhakar Reddy.

Highly accomplished process chemist with extensive experience in pharmaceutical R&D and manufacturing. Proven track record in leading end-to-end process development from laboratory through technology transfer to manufacturing. Strong background in cGMP compliance, cross-functional collaboration, and mentoring scientific teams-Drug substances synthesis, small API\'s, high potent drugs, Peptides, Polypeptide, Peptide mimics, Nucleic acid and Oligonucleotide synthesis. Crystallization & Purification Techniques, Polymorphisms-Analytical tools; NMR, LCMS, HPLC, UPLC, RP-HPLC, Peptide mapping, Amino acid analysis, SEC MALLS,N-termini, C-termini analysis, sameness analysis etc-Instrumental: QbD, DOE, PAT,SPPS, LPPS, Microwave-assisted synthesis (CEM Liberty Blue/PRO, SONATA), RP-HPLC, Preparative HPLC, Ion-exchange chromatography (IEC), tangential flow filtration (TFF), Crystallization, Dialysis, Centrifugal Filtration-Electronic Lab Notebook (ELN), ChemDraw, SciFinder, Reaxys, Minitab, Microsoft Office Suite-Milli gram(mg) to kilo grams ((kg), scale up, manufacturing, execution, USFDA, Regulatory support, DMF filing, cGMP/GLP guidelines, CPP, FMEA, PAT tools, quality-CAPA, deviations, Route cause identification & controls strategies, Genotoxic impurities (GTI), nitrosamine impurities, control strategies, fate purge study. Design and execute multi step organic synthesis, isolation, and purification of API molecules-CDMO development, laboratory synthesis, purification strategies, scale up techniques-Lead end to end process development activities, delivering scalable, reproducible, and regulatory aligned API processes. Comprehensive technical reports, development summaries, and conclusions-Safe laboratory operations, safety rules, maintaining compliance with EHS requirements-Collaboration with manufacturing teams, GMP compliant process execution, technical guidance during scale up-Handling controlled substances (CS) in accordance with DEA regulations, ensuring full compliance during storage, handling, and usage in drug synthesis-Managed multiple projects, timely updates to clients, time delivery of project milestones-Project ownership and accountability, timelines, development progress, effective communication, cross functional teams handling.

Experience

1. Senior Scientist-ii

   Cambrex

   Oct 2023 — Present · US

   Design and execute multistep organic synthesis and process development for drug substance (API\'s) and intermediate molecules, encompassing reaction optimization, isolation, and purification using crystallization techniques to ensure high yield and purity across all development stages-Skilled in crystallization, purification techniques, impurity profiling, and DEA-compliant handling of controlled substances-Proven leader in managing concurrent projects, optimizing processes for robustness and cost efficiency, and ensuring GMP-compliant, regulatory-aligned manufacturing-Strong collaborator across analytical, QA/QC, and manufacturing teams, consistently delivering high-quality technical documentation and meeting critical project milestones for clients-cGPM guidelines, CAPA, Fate purge studies, safety studies evolutions, safety guidelines, justification reports, Cross functional teams handling.

Education

• UMass Chan Medical School

  Senior Research Scientist, Oligonucleotide synthesis, Purifications, modifications, Nucleic acids, DNA RNA therapeutics

• PhD at Osmania unniversity

  Doctor of Philosophy - PhD, Organic Chemistry

  2008 — 2014