Carlos Martínez Manchado

• ***** Fairview Dr • Orange Village, Ohio 44022 •

• Mobile: 786-***-**** • Voice & Fax: 440-***-**** • e-mail: abnzq6@r.postjobfree.com •

OBJECTIVE

Lead Scientist with eight (8) years of experience in the pharmaceutical industry working at Contract Research Organizations

(CRO), with experience in activities such as, but not limited to: analytical method development and validation, applied

synthetic organic chemistry, and complete physical-chemical characterization of pharmaceutical products; seeking a scientific

leadership role or related scientific position at a pharmaceutical company.

EXPERIENCE

Ricerca Biosciences LLC (CRO) Concord, Ohio. 07/2010 – Present.

Analytical Chemistry Scientist

Scientist at the Analytical Chemistry Group. Technical proposal writing, planning, setting -up and execution of

experiments, regular technical meetings with clients, data processing, analytical test method wri ting, validation protocol

design/writing, scientific report writing.

Areas of application:

Analytical method development and validation (ICH compliant): Stability-indicating HPLC-UV methods (Assay

o

and Purity), quantitative determination of residuals and impurities in drug substances and drug products by HPLC-

MSMS Multiple Reaction Monitoring (MRM), derivatization Chemistry for analytical purposes (e.g. GC-MS), and

quantitative determination of counterion by IC (DIONEX technology).

Identification, isolation, and characterization of impurities and degradants in pharmaceuticals, involving techniques

o

such as Semi-preparative & Preparative HPLC, HPLC-UV/MSMS, 1D and 2D NMR, FTIR, etc. (e.g. Identification,

isolation, purification, and structural characterization of all major stability-related impurities of Optimer’s

Fidaxomicin)

Qualitative analysis of impurities and residuals by HPLC -MSMS for molecular structure assessment to support

o

process chemistry.

Structural characterization of drug substances and other synthesis intermediates by Mass Spectrometry.

o

Extractable and Leachables (E&L) studies (GC-MS, HPLC-MS)

o

Migration Studies on poly-hydroxyalkanoate (PHA) bio-polymers intended to be used in Food Industry field.

o

Pharmaceutical Sciences Consultant Miami, Florida. 04/2010 – 07/2010.

Consultant

Soon after Bank of America terminated Azopharma operations, some clients approached me, with the intention of

rescuing and securing critical data, experimental results, and samples/materials of interest, part of their ong oing projects.

Because of my personal involvement on each single project, I was successfully able to gather all relevant data, from

NMR to HPLC-MSMS, process the data, collect all samples/materials, and provide the clients with technical/scientific

reports in behalf of Azopharma Contract Pharmaceutical Services Research and Development group.

Azopharma Drug Development Services (CRO) Miramar, Florida. 07/2004 – 04/2010.

Positions held (starting from most recent):

R&D Director; R&D/Synthesis Manager; Structural Chemistry Group Leader; Scientist; Chemist II

Managed all groups in the R&D department, supervising a team of chemists/scientists; including Analytical and

Bioanalytical Method Development, Method Validation under ICH guidelines, Organic Synthesis, Structural Chemistry,

and Characterization.

QC related activities: Raw materials, API, and finish product release; analytical tests as part of ICH stability programs.

R&D related activities: deformulation of pharmaceutical products, synthesis and semi-synthesis of organic compounds

for analytical applications, identification-isolation-characterization-synthesis of impurities/degradants in pharmaceutical

products, among other activities.

Examples of areas of development and scientific applications:

Execution of analytical procedures such as Identification, Assay, Chromatographic Purity, Content Uniformity, and

o

Dissolution, as part of release activities and stability programs under ICH guidelines.

Analytical method development and validation under cGMP environment and ICH guidelines.

o

Design and execution pre-formulation and compatibility studies to support the development of new drug products.

o

Extractables and Leachables studies.

o

Reverse engineering (de-formulation) of various types of pharmaceutical products: cre ams, tablets, gels, etc.

o

Page 1

Carlos Martínez Manchado

• 31600 Fairview Dr • Orange Village, Ohio 44022 •

• Mobile: 786-***-**** • Voice & Fax: 440-***-**** • e-mail: abnzq6@r.postjobfree.com •

Full structural and physicochemical characterization of analytical standards and new drugs (Structural elucidation,

o

1D and 2D NMR, IR, UV-Vis, Solubility, Polymorphism, Log-P, pKa determination, Intrinsic dissolution, etc .)

Identification of impurities and degradants in finish products as part of stability studies under ICH guidelines.

o

Development of new and alternative synthetic methodologies, isolation, and characterization of impurities/degradant

o

to support compatibility/stability studies and to produce qualified analytical reference materials (e.g related

substances of Morphine, Chlorhexidine, Laidlomycin, Ketotifen, Fidaxomicin, among others API).

PEGylation Chemistry. Synthesis of Heterobifunctional-PEGs and PEG-Peptides conjugates (polymer chemistry).

o

Molecular Structure Modeling and prediction of structural-related properties.

o

Execution of Compendial testing (USP, EP, JP)

o

Write Investigations (OOS and OOT) and Deviation documentation in accordance with SOPs.

o

Industrial Automation and Control Process. MTI2000 c.a. Puerto Ordaz, Venezuela. 01/2001 – 04/2004.

Developer position, Technical Staff

SIEMENS SIMATIC S7 Automation Technology Integration. Process Control.

HMI/SCADA development for Automatic Process Supervisory Systems, iFIX Intellution Technology.

Simón Bolívar University, Department of Chemistry Caracas, Venezuela. 04/1995 - 10/2000.

Research and Academic Staff

Isolation and identification of Terpenoids from tropical medicinal plants. Research. 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, UV-Vis, and QSAR.

Computer aided molecular modeling application for structural analysis, Nuclear Magnetic Resonance spectrum

interpretation and structure-activity relationships (QSAR) study.

Taught organic chemistry lab and practical course of spectroscopy and structural elucidation of organic compounds.

Bio-organic Institute Antonio González,

La Laguna University Tenerife, Islas Canarias, Spain. 01/1997-03/1997.

Research Staff. INTERCAMPUS/AL.E., Academic Interchange P rogram.

Marine and terrestrial natural products chemistry. Biologically active organic compounds isolation and identification.

Techniques used: LC, GC-MS, HPLC, IR, and FT-NMR (1D and 2D).

Pharmacy and Food Institute (IFAL), Havana University. Ciudad de La Habana, Cuba. 1993-1994.

Academic and Research Staff.

Pharmaceutical Chemistry I & II. Theory.

Advanced Organic Chemistry and Drug Synthesis. Theory.

Bioorganic Chemistry III (Stereochemistry). Practical/Lab course.

Pharmaceutical Chemistry II. Practical/Lab course.

Isolation and identification of biologically active alkaloids from medicinal plants (Natural Product Chemistry).

EDUCATION

Simón Bolívar University

Caracas, Venezuela. 04/1995-10/2000.

Postgraduate studies. (M.Sc. and Ph.D. program degree (thesis not defended))

Major: Organic Chemistry (Natural Products Chemistry) (GPA 4.9148 / 5)

Instituto de Farmacia y Alimentos - IFAL (Pharmacy & Food Institute), Universidad de La Habana (Havana

University).

Ciudad de La Habana, Cuba. 1988-1993.

Bachelor of Science (BS).

Major: Pharmaceutical Sciences (GPA 4.50 / 5)

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Carlos Martínez Manchado

• 31600 Fairview Dr • Orange Village, Ohio 44022 •

• Mobile: 786-***-**** • Voice & Fax: 440-***-**** • e-mail: abnzq6@r.postjobfree.com •

PUBLICATIONS & EVENTS

Anti-Inflammatory Sesquiterpene Lactones from Lourteigia ballotaefolia. Alfredo Rosas-Romero, Carlos Martínez

Manchado, Oscar Crescente, Mercedes Acosta, Massimo Curini, Francesco Epifano, Maria Carla Marcot ullio, Ornelio

Rosati, Aurelia Tubaro, Silvio Sosa. PLANTA MEDICA, 843 -845, 2002.

A novel approach to quantitative structure -property relationships (QSPR) in antioxidants. Alfredo J. Rosas romero,

Benjamin Rojano, Carmen A. Hernández, Carlos Martínez Manchado, Judith Silva y Julio C. Herrera. CIENCIA, 7(1),

78-87, 1999, Maracaibo, Venezuela.

Isolation and identification of biologically active principles from Ceratosanthes palmata roots (Aislamiento e

identificación de Metabolitos biológicamente activos en la raíz de Ceratosanthes palmata). Rosas Romero A. J.,

Martínez C., Crescente O. y Acosta M. ASOCIACIÓN VENEZOLANA PARA EL AVANCE DE LA CIENCIA

(AsoVAC)’98, XLVIII Convención anual, Universidad “Rafael Belloso Chapín”, Maracaibo 9 al 14 de noviembre, 1998.

Nuovi Germacranolidi da Eupatorium ballotaefolium (Compositae). P. Cecherelli, M. Curini, M. C. Marcotullio, O.

Rosati, A. J. Rosas-Romero, C. Martínez, O. Crescente. Convengo Scientífico: “Piante officinali: Attualitá e Prospecttive

Scientifiché”, Roma, 20-21 Giugno, 1997.

Aplicación de la Cromatografía de gases / espectrometría de masas (GC/EM) al análisis de las lactonas sesquiterpénicas

de Eupatorium ballotaefolium. A Rosas-Romero, C. Martínez y L. Kurtz. III Congreso Venezolano de Química, Caracas,

10-14 de noviembre, 1996.

Relación estructura-actividad en antioxidantes fenólicos. A. Rosas Romero, Y. Silva, B. Rojano y C. Martínez. III

Congreso Venezolano de Química, Caracas, 10-14 de Noviembre, 1996.

Influence of pH on the degradation of Ornidazol. Iso lation and identification of its degradation products. J.R. Valdez

Santurio, J.A. Martínez Perez, B. Lopez Pelaez and C. Martínez Manchado. S. T. P. PHARMA SCIENCES, 5(5), 391 -

395, 1995.

SKILLS

Chemistry related: HPLC (Waters, Hitachi, Perking Elmer, Agilent; normal-phase, reverse-phase, SEC, GPC, preparative),

Ion Exchange Chromatography (DIONEX technology), GC, GC/MS (HP), Advance NMR (1D, 2D[COSY, TOCSY,

NOESY, HMQC, HMBC, DEPT, and Other], 1H, 13C, 31P, 19F), IR, UV-Vis, HPLC-UV/MS (Waters Micromass, Thermo

Finnigan, API, Q-Trap), MS/MS, HRMS, Thermogravimetric Analysis (TGA), Differential Scanning Calorimetry (DSC),

PXRD, Dynamic Vapor Sorption (DVS), General Wet Chemistry, Advanced Organic Chemistry (Synthesis,

Isolation/purification (TLC, LC, etc.), and characterization), Dialysis, Tangential Flow Filtration (TFF), Optical Microscopy,

Molecular Structure Elucidation, Scientific and Technical writing.

Computer related: Advance Microsoft Office (Word, Excel, PowerPoint, and Access), Database (Access, SQL), Molecular

Modeling (Chem3D, Hyperchem, Spartan), HPLC, GC and MS Software (Totalc hrom, Chemstation, Xcalibur, MassLynx,

and Analyst®). Image Processing. NMR data processing (Mestrelab Mnova, Bruker TOPSPIN)

Others: Fluent in English and Spanish

References:

J. Blair West, Ph. D. Brittany L. Hayes, Ph.D. Yanmei Lan, Ph. D.

abnzq6@r.postjobfree.com 619-***-**** (Cell) 609-***-**** (Cell)

PharmaForm abnzq6@r.postjobfree.com abnzq6@r.postjobfree.com

PharmaForm Cubist Pharmaceuticals

Sheena Szuri Elena Korobetskaya, Ph.D. Sulan Yao, Ph.D.

786-***-**** (Cell) 858-***-**** (Tel) 858-***-**** (Tel)

abnzq6@r.postjobfree.com abnzq6@r.postjobfree.com Optimer Pharmaceutical, Inc

Noven Pharmaceuticals Sangart, Inc.

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