Associate Principal Scientist

YURIY B. KALYAN, Ph. D.

** ********* **. ****** ******, NY 10305

Home: 718-***-****

Mobile: 917-***-****

E-mail: acvmct@r.postjobfree.com

HIGHLIGHTS:

Synthetic organic chemist with over thirty years academic and pharmaceutical industrial experience in medicinal and process chemistry.

Expertise in multistep organic synthesis (milligram to kilogram scale).

Experienced with cGMP, ICH and regulatory guidelines for Drug Substance

Prepared Drug Substance CMC sections for multiple regulatory submissions.

Proven ability to work independently and as a member of a multi-disciplinary team.

Technology transfer

SUPPORTED ANALYTICAL METHODS:

Chromatography: Column, Thin Layer, GC, HPLC/UPLC, prep. HPLC

Spectroscopy: FT-IR, NMR, LC/MS, and UV

PROFESSIONAL EXPERIENCE

2011-2015 Associate Principal Scientist, Actavis (former Forest Research Institute Inc.), Chemical Development, Hauppauge, NY

Developed multiple novel synthetic approaches for key pipeline products that

provided robust, safe and cost effective chemical processes for API manufacture

Chemical development for Eluxadoline® (IBS) project: Identified and optimized scalable synthetic routes resulting in significant cost reduction Eluxadoline®.

Designed and developed a novel solution phase synthesis of an octapeptide protein and coordinated transfer of projects from in-house development to CROs, developed IP

As a lab manager, supported all chemical and equipment purchasing needs for the department and provide required technical support for preparing capital budget proposals.

2009-2010 Principal Investigator, Forest Research Institute Inc., Chemical Development, Hauppauge, NY

Designed & developed an alternate route for cost-effective toward Dutogliptin®, a dipeptyl peptidase-4 inhibitor; allowing significant cost-savings over vendor pricing (COGs was reduced from $15000/kg to $1400/kg).

Responsible for the transfer of this technology to API manufacturing plants

Responsible for synthesis development, scale-up (gram to multi grams), and plant support for the GMP API production of clinical drug candidates

Tech transfer package for the synthesis of β-lactam was prepared and given to outside CRO. Managed all steps of manufacturing, resolved obtained problems

Developed telescopic synthesis of NXL104 starting from OO

2003-2008 Senior Research Scientist, Forest Research Institute, Forest Laboratories, Inc., Commack, NY.

As a Head of Raw Material Release Group coordinated all analyses, reports, etc. for releasing all API, excipients used for drug product manufacture as well as was responsible for purification, certification and recertification of In-house reference standards

1993-2003 Research Scientist of Medicinal Chemistry Laboratory, Forest Laboratories, Inc., Inwood, NY.

Optimized the procedure of preparation and synthesized a new bulk drug

Prepared documentation for IND Filing

Reviewed the Vendor’s CMC regulatory filings for Drug Substances

Synthesized and purified drug metabolites and impurities of existing APIs

Synthesized labeled with 13C and/or deuterium atoms APIs and metabolites

1975-1992 Scientist, Moldavian Academy of Sciences, Institute of Chemistry, Laboratory of Organic Synthesis, Kishinev, Moldova.

Synthesized and designed novel triazol-containing compounds to optimize pesticide activity

Investigated the Claisen Reaction on the surface of adsorbents

Synthesized sulfur containing cation reagents, sulfonium and episulfonium salts and examined their reactions with alkenes: low-temperature and organometallic synthesis.

Extracted steroid glycosides from plants and determined the structure of isolated compounds

EDUCATION (Degree Related)

1984Ph.D. in Organic Chemistry, Zelinsky Institute of Organic Chemistry, Moscow, USSR.

Dissertation Title: New Possibilities of Synthesis and Applications of Sulfonium and Episulfonium Salts.

1975 M.S. in Chemistry, Kishinev State University, Kishinev, Moldavian SSR.

Major: Organic Chemistry

Minor: Analytical Chemistry

Thesis Title: Two Triterpenoid Glycosides from Clematis Orientalis.

PROFESSIONAL AFFILIATIONS AND ACTIVITIES

American Chemical Society (Organic Chemistry Division)

PUBLICATIONS: more than 30 publications and 11 patents

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