Human Resources A Dedicated

Srinivasa Rao Meneni

Tel. 1-401-***-**** Email: ********@*****.***

Visa Status: Permanent Resident (USA)

SUMMARY

●Extensive experience in working multi-disciplinary environment, collaborating with various departments. Proficient practical experience in Analytical chemistry, Medicinal chemistry and/or Natural Product Chemistry.

●Skilled in method development, validation, and transfer of analytical methods under regulatory guidelines such as GMPs, ICH, FDA, USP and internal SOPs. Demonstrated proficiency in analytical method transfers within GMP environments, with over 10 years of experience in pharmaceutical and biotech industries.

●In-depth knowledge of synthesis, purification, and characterization of organic compounds (peptides, Proteins, aminoglycosides, carbohydrates, nucleosides, oligonucleotides, and natural products) on small and medium scale.

●Well-versed in the purification of modified oligonucleotides with HPLC/UPLC, AKTA and FPLC. Expertise in Biophysical and Bioanalytical experiments.

●Published multiple research papers in highly reputed international journal, wrote SOPs, validation protocols, final reports and invited book chapter article.

●Extensive experience in designing, synthesizing identifying leads, and optimization of small molecules as potential drug candidate.

●Experienced in CMC and CRO pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s.

●Knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development.

●Expert in the analysis of 1D (1H, 13C, 19F, 15N, DEPT, NOEDS), 2D (COSY, HMBC, HMQC, NOESY) NMR, and mass spectra (EI, ESI, CI, FAB and MALDI). Proficient in recording and interpretation of FT-IR, CD, UV/VIS and optical rotation data.

EMPLOYMENT HISTORY

Eurofins- Worcester, MA 08/2023-02/2024

Research Fellow

●Conduct method feasibility studies for oligonucleotides and small molecules in alignment with company priorities and regulatory guidelines.

●Analysis of API at all stages of development. Provide method development and validation using HPLC/UPLC, GC, ICP-MS and related techniques.

●Develop analytical methods and protocols for testing of oligonucleotides and small molecules, ensuring compliance with regulatory requirements.

Biogen- Cambridge, MA 09/2021-12/2023

Principal Small Molecule Scientist

●Method development and validation for small molecules Active Pharmaceutical Ingredients (APIs), drug substances (DS) and drug products (DP) using HPLC/UPLC.

●Skillfully designed, supported, and analyzed method transfer and validation activities across a late-phase portfolio of small molecules.

●Performs laboratory analyses of raw materials, finished products (FP) and stability (ST)

Conducting analysis of API at all stages of development. Provide method development and validation using HPLC, GC, NMR, ICP-MS and related techniques.

●Execute routine activities for drug product preparation: formulate blends, tablets, and capsules. And characterize the hardness of tablets, friability, and disintegration.

●Collaborated seamlessly with cross-functional teams in technical operations, quality, and regulatory CMC partners.

●Successfully transferred validated analytical methods to production teams, facilitating seamless implementation into manufacturing processes.

●Authored and reviewed essential documents for each method transfer, ensuring compliance with regulatory standards and internal protocols.

Wisdom Natural Brands- Gilbert, AZ 08/2014-08/2021

Principal Scientist-Analytical Chemistry

●Developed and validated analytical methods to ensure accuracy, precision, specificity, linearity, and robustness for analyzing natural products, in compliance with regulatory guidelines and industry standards.

●Led and managed a team of analytical chemists in the developing and implementing of analytical methods for the characterizing and controlling the quality of natural products.

●Designed and executed analytical experiments to isolate, identify, and quantify active compounds from natural sources, utilizing a range of analytical techniques such as HPLC, LC-MS, GC-MS, NMR, and spectroscopic methods.

●Extensive work with nutritive and non-nutritive sweeteners in various beverage applications for Wisdom Natural brands.

●Collaborated with interdisciplinary teams, including researchers, pharmacologists, and formulation scientists, to support natural product drug discovery, development, and formulation.

●Researched and evaluated new ingredients in company pipeline in several beverage applications for ingredient launches.

PCI Synthesis – Newburyport, MA 02/2012-02/2014

Analytical Method Development Scientist

●Responsible for planning, executing, and documenting the qualification and monitoring of third-party suppliers who source API raw materials and drug product materials.

●Conducting analysis of API at all stages of development. Provide method development and validation using HPLC, GC and related techniques.

●Analytical services for multiple projects in a contract pharmaceutical environment. Analysis of API at all stages of development. Provide method development and validation using HPLC, GC, ICP-MS and related techniques.

●Responsible included: planning, execution, and documentation of the qualification and monitoring of third-party suppliers who are sourcing API raw materials and Drug product materials.

●Developing and validating methods for chiral/achiral small molecules using HPLC, GC, GC-MS, LC-MS, NMR, FT-IR, KF and supporting techniques. Impurity profiling, assay, structure elucidation, and standard qualification

Select pharmaceuticals – Worcester, MA 04/2006-12/2011.

Senior Scientist- Analytical chemistry

●Leveraged specialized knowledge in peptide chemistry to enhance method transfer processes, contributing to project success.

●Characterized of compounds (novel/known) isolated from fermentation broths and synthetic derivatives, impurity isolation, stability studies of natural and synthetic compounds, quantification, etc. Techniques used to include, LC-MS, UV/VIS, ELSD, NMR, UPLC, HPLC, GC, column chromatography, etc.

●Developed and optimized LC-MS methodologies for the analysis of complex protein samples, achieving a 20% improvement in sensitivity and a 15% reduction in analysis time.

●Conducted comprehensive protein characterization studies using LC-MS, including post-translational modification analysis, protein quantification, and structural elucidation.

●Coordinated project activities across multifunctional department lines and collaborated strategic alliance partners to shape research strategies aimed at advancing the identification of a clinical development candidate.

University of Rhode Island – Kingston, RI 09/2003-03/2006

Research Scientist (Advisor: Prof. Bongsup Cho)

●RP-HPLC method development of fluoro amino fluorene-modified oligonucleotides.

●Synthesis of arylamine carcinogens and modification of oligonucleotides.

●Purification of modified and unmodified oligonucleotides using RP-HPLC .

●Characterization of modified oligonucleotides through exonuclease enzyme digestion and MALDI-TOF analysis.

●Structural and conformational analysis of modified oligonucleotides using NMR (1H and 19F), CD and Fluorescence spectroscopy.

●Thermal and thermodynamic characterization of oligonucleotides using UV-spectrophotometer, CD and DSC.

●Writing papers, reports and present the research results in national & regional meetings.

Oakland University – Rochester hills, MI 05/2001-08/2003

Postdoctoral Fellow (Advisor: Prof. Roman Dembinski)

●Design and discovery of compounds for the treatment of various emerging infectious diseases.

●Performed structure-based drug design and synthesis of nucleoside analogs as anti-viral agents against HIV, Hepatitis B & C, and Herpes, Respiratory, Orthopox, Biodefense viruses & Cancer.

●Accomplished a new method of synthesis of new synthetic methodology of 5-endo-dig electrophilic cyclization of α-alkynyl carbonyl compounds and extensively explored related nucleoside analogs as potential antiviral and anticancer agents.

●Synthesized and ESR studies of alkynyl- tethered 2'-deoxyuridines and their bicyclic pyrimidine analogues.

Paderborn University – Paderborn, Germany 04/2000-03/2001

Postdoctoral Fellow (Advisor: Prof. Kristen Krohn)

●Isolation and identification of Terpenoids from tropical medicinal plants. Extensively used techniques: GC- MS, 1D & 2D FTNMR, FTIR, HPLC, Low–Pressure Chromatography (LC, analytical and preparative) and TLC (analytical and preparative).

●Structure-Activity relationships studies of natural and synthetic antioxidant organic compounds. Used techniques: GC- MS and UV-Vis.

EDUCATION

PhD, Organic Chemistry (Advisor: Srinivasarao Poruri) 1998

KAKATIYA UNIVERSITY– WARANGAL, AP, INDIA

Master of Science, Analytical Chemistry 1993

ANDHRA UNIVERSITY– VISHAKAPATNAM, AP, INDIA

Bachelor of Science, (Chemistry, Physics, Math) 1990

KAKATIYA UNIVERSITY– WARANGAL, AP, INDIA

PUBLICATIONS

Number of publications: 35

1)Cho, Bongsup; Jain, Nidhi; and Rao, M.S. Influence of flanking sequence context on the conformational flexibility of aminofluorene-modified dG adduct in dA mismatch DNA duplexes. Nucleic Acids Res.2009. 37: 1628-1637.

2)Adam Sniady, Michael D. Sevilla, Rao, M.S, Tadeusz Lis, Sawomir Szafert, Deepthi Khanduri, John M. Finke, and Roman Dembinski, Synthesis and ESR studies of 2'-deoxyuridines tethered with alkynyl, rod-like linkages, Chem. Eur. J. 2009, 15, 7569 – 7577.

3)Sergeant, C.D.; Ott, I.; Sniady, A.; Rao, M.S.; Gust, R.; and Dembinski, R. Metallo-Nucleosides: Synthesis and Antiproliferative activity of Hexacarbonyl dicobalt 5-alkynyl-2'-deoxyuridines. Org. Biome. Chem. 2008. 6(1), 73-80.

4)Rao, M.S.; Steven M.S.; Yue, Z and Cho, B.P. Sequence Effects on the Conformational Heterogeneity of Aminofluorene- Derived DNA Adducts and Incision by UvrABC Nuclease Repair. Chem.Res. Toxicol. 2007, 20, 6-10

5)Rao, M.S.; Zou, Yue; Chiarelli, Paul; Lee, Wang; Šponer, Jurecka, Petr and Cho, B.P. Spectroscopic and Theoretical Insights into Sequence Effects of Aminofluorene-induced Conformational Heterogeneity and Nucleotide Excision Repair. Biochemistry.2007, 46(40), 112**-*****.

6)Rao, M.S and Cho, B.P. 19F NMR modeling for the translesion synthesis of aminofluorene-dG adducts. J.Mol.Biol. 2007, 366, 1387-1400.

7)Jain, Nidhi; Li, Yuyuan; Zhang, Li; Rao, M.S and Cho, Bongsup Probing the sequence effect on NarI-induced-2 frame shift mutagenesis by dynamic 19F NMR, UV and CD spectroscopy. Biochemistry.2007; 46(46); 133**-*****.

8)Rao, M.S.; Sergeant, C.D.; Ott, I and Dembinski, R. Chromatography-Free Synthesis of 5-Alkynyl-2'-Deoxyuridines and Cytotoxicity Studies Against MCF-7 and MDA-MB-231 Human Breast Cancer Cells. Borg. Med. Chem. 2007, 15, 3082-3088.

9)Liang, F.; Rao, M.S and Cho, B.P. Novel Induced Circular Dichroism Characteristics as Conformational Probes of Aminoflurorene-induced Conformational. Chem.Res.Toxicol. 2006, 19, 1040-43.

10)Rao, M.S.; D’Mello, R.; Norigian, G.; Baker, G.; Gao, L.; Chiarelli, P.M and Cho, B.P. Sequence effects of aminofluorene-modified DNA duplexes: UV thermodynamic and circular dichroism properties. Nucleic Acids Res.2006, 34(2), 755-764.

11)Rao, M.S.; Esho, N.; Sergeant, C and Dembinski, R. 5-endo-dig electrophilic cyclization of α-alkynyl carbonyl compounds: Synthesis of novel bicyclic 5-iodo- and 5-bromofurano pirymidine nucleosides. J. Org. Chem. 2003, 68(17), 6788-6970.

12)Rao, M.S and Krohn, K. Isolation and Synthesis of chalcones with different degrees of saturation. Phytochemistry. 2002, 61(8), 931-936.

13) Rao, M.S.; Raman, N.V. and Krohn, K. High-performance thin layer chromatographic analysis of anti-inflammatory triterpenoids from Boswellia serrata Roxb. Phytochemcal Analysis. 2001, 12(6), 374-376.

14)Rao, M.S.; Rao, P.S.; Toth, G.; Balzs, B and Duddeck, H. Isolation of Polyarvin, a New Prenylated Chalcone from Polygala arvensis, Natural Product Letters. 1998, 12(14), 227-230.

15)Rao, M.S.; Rao, P.S.; Toth, G.; Balzs, B and Duddeck, H. A Revised Structure for Crotaramosmin from Crotolaria ramosissima. J. Nat. Prod. 1998, 61(9), 1148-49.

Patents

4,6-Substituted 2,5-Dideoxystreptamine Aminoglycoside Antibiotics4,6-Substituted 2,5-Dideoxystreptamine Aminoglycoside Antibiotics

US US 201******** A1 · Issued Aug 8, 2013

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