HITEN JAYANTI GUTKA

#G-*, **** Anderson Road, Oxford, MS-38655. Email: abgins@r.postjobfree.com Phone: 312-***-****.

Research Interest: Process, Analytical and Formulation development for protein therapeutics (Biologics).

Summary Statement: Skilled in process, analytical method and formulation development with emphasis on

biochemistry techniques to elucidate the structure and function of protein therapeutics. To secure a challenging

position in protein formulation and analytical development area in a pharmaceutical biotechnology based

organization, wherein I get to utilize my skills and experience and the opportunity for career advancement and

continuous learning.

EDUCATION

Thesis Defense

PhD Pharmacognosy (Pharmaceutical biotechnology), University of Illinois at Chicago.

•

Nov 2012

GPA = 3.64

2004

MS Pharmaceutical Sciences, University Institute of Chemical Technology (UICT),

•

University of Mumbai. GPA = 4.00

2002

BS Pharmaceutical Sciences, University of Mumbai. GPA = 3.96

•

QUALIFICATIONS

Trained in experimental techniques used in research and development in the biotechnology industry including:

• Protein formulation and development. • Aseptic technique, parenteral dosage forms

• Stability Studies on protein formulations • Process related impurity characterization

• Analytical chromatography (RPHPLC, SEC, IEX) • Mycobacterial genetics

• Differential scanning calorimetry (DSC) • Prokaryotic molecular biology techniques

• UV spectroscopy • Protein expression and purification

• Particle sizing by DLS • Protein crystallization, Structural biology

• Technology transfer (Research to pilot scale) • Enzymatic assay development and kinetics

Trainings “HPLC instrumentation and troubleshooting” at Agilent Technologies, Singapore. December 2005.

“Basic HPLC instrumentation and use of EMPOWER Software” at Waters, India. October 2005.

“Validation of Computerized HPLC systems - Validation School” at Waters, India March 2007.

Software Microsoft Office (Word, PowerPoint, Excel), Chromatography (Unicorn, Chemstation, Empower),

GraphPad Prism, Structural biology (Coot, PyMol).

INDUSTRY EXPERIENCE

Summer Intern, Formulation sciences, Medimmune LLC. Supervisor: Dr. Deborah Goldberg Jun 2012

• Evaluated the effect of formulation variables (pH and ion strength) on the solution state stability – Aug 2012

of high concentration monoclonal antibody formulations.

• Performed biophysical characterization (conformational and colloidal stability) of monoclonal

antibody (IgG4) formulations.

Sr. Executive Biopharmaceuticals, Quality, Reliance Life Sciences. Supervisor: Benjamin May 2007

– Jul 2008

Stephen

• Successfully validated analytical chromatography assays for three biogeneric proteins.

• Planned and executed stability studies for clinical lots of GCSF.

• Represented the Quality function on CMC team at fill-finish contract manufacturing facility for

three protein formulations (Relipoetin (Erythropoetin), Religrast (GCSF) and Reliferon

(Interferon alfa 2b) in prefilled syringe format).

• Managed four Associates performing analytical testing in process, fill finish and stability.

• Modified process and proposed a formulation change for GCSF (special grade of Tween 80) to

minimize the oxidized impurities.

• Implemented additional purification step (TFF) post pasteurization for albumin liquid formulation

resulting in an improved aggregation and high molecular weight impurity profile for the product

to meet all compendial (BP, Ph. Eur., USP) requirements.

Feb 2006

Sr. Executive Biologics QA, Pilot plant, USV Limited. Supervisor: Rajshekhar Reddy

– May 2007

• Transferred analytical methods from Development to Pilot plant Quality for two biologics.

• W orked on CMC team (quality function) for lyophilized formulation development of rHGH at

H.J. Gutka 2/3

contract manufacturing facility. PEG-GCSF laboratory scale process development

• Performed product release and stability studies of rHGH clinical lots.

Sep 2004

Executive QA Biopharmaceuticals, Quality, Biocon Limited. Supervisor: Benjamin Stephan

– Jan 2006

• Performed release testing and stability for human insulin drug substance (6 lots) and injectable

formulations (34 lots).

• Managed quality function for insulin parenteral formulation manufacturing campaign at contract

fill-finish manufacturing site.

RESEARCH EXPERIENCE

Graduate Research:

Goal: Identification and validation of novel drug targets in Mycobacterium tuberculosis (Mtb), to aid Aug 2008

the process of structure based drug discovery. This approach is of high relevance in the context of - Present

antibacterial drug resistance and the prevalence of multi drug resistant and extensively drug

resistant Mtb strains. The problem of drug resistance is compounded by non-availability of new

drugs or the lack of interest among pharmaceutical companies to work on such drugs.

• Studied essential genes in Mtb as potential antibacterial drug targets.

• Validated glpX gene as a potential drug target in Mtb by generating its deletion knock-out

followed by phenotypic characterization of the glpX KO strain.

• Purified and performed biochemical characterization of glpX encoded fructose 1, 6-

bisphosphatase (MtbFBPase).

• Solved the crystal structure of MtbFBPase (APO and catalytic product complex structure).

• Over expressed 4 difficult to purify Mtb proteins in several expression host systems (E. coli, M

smegmatis). Developed strategies to address soluble expression of Mtb proteins.

Relevant Coursework: Biochemistry, Molecular biology, Drug discovery and development, Research methods

in Biochemistry, Receptor pharmacology, cell signaling, Structure of Biopolymers.

OTHER EXPERIENCE

Teaching experience; Teaching Assistant in following courses in the professional PharmD

program of the College of Pharmacy:

Fall 2008

• PHAR332 Fundamentals of Drug Action II: Graded tests, managed blackboard site,

coordinated with testing services (on-campus) for test reports/grading, answered student

queries (office hours)

• PHAR 333 Fundamentals of Drug Action III: Graded tests, answered student queries (office Spring 2009

hours)

May 2010

Student mentor for undergraduate students at Harold Washington University (City College of

- May 2011

Chicago)

Sep 2012

Student representative in the steering committee for Sterile Product focus group of the AAPS

HONORS AND AWARDS

May 2012

AMGEN’s Travelship to present at National Biotechnology Conference, San Diego

•

Fall 2010

W .C. and May Deiss Award for Biomedical Research, Graduate College UIC.

•

Jan 2011

Bill and Melinda Gates foundation Global health travel award, Keystone symposia (J4)

•

Mycobacteria: Physiology, Metabolism and Pathogenesis, Vancouver, Canada.

April 2010

Image of Research competition Graduate College UIC Finalist “Crystals the Magic of Life in

•

Different Forms”.

April 2011

Third Place in UIC, College of Pharmacy (COP) Image of Research Competition.

•

2002 - 04

Junior Research Fellowship (UGC), University Institute of Chemical Technology,

•

2001 - 02

Gold Medalist University of Mumbai in Bachelor of Pharmaceutical Sciences Year.

•

PUBLICATIONS

H. J. Gutka, K. Rukseree, P. R. Wheeler, S. G. Franzblau, F. Movahedzadeh. glpX Gene of Mycobacterium

•

tuberculosis: Heterologous Expression, Purification, and Enzymatic Characterization of the Encoded

Fructose 1,6-bisphosphatase II. Appl Biochem Biotechnol (2011), Aug;164(8):1376-89.

Gutka, H.J. Franzblau, S.G. Movahedzadeh, F. Abad-Zapatero, C. Crystallization and preliminary X-ray

•

characterization of the glpX-encoded class II fructose-1,6-bisphosphatase from Mycobacterium tuberculosis.

Acta Cryst Section F Structural Biology and Crystallization Communications (2011), 67 (Pt 6):710-3.

Movahedzadeh, F. Frita, R. Gutka, H.J. A two-step strategy for the complementation of M. tuberculosis

•

H.J. Gutka 3/3

mutants. Genetics and Molecular Biology (2011), 34(2), 286-289.

Gutka H. J., Laddha K. S. An insight into Aloe vera, Chemical Weekly March 2004.

•

Gutka H. J., Laddha K. S. An insight into Aloe vera Part II, Chemical Weekly August 2004.

•

ABSTRACTS AND PRESENTATIONS

H. J. Gutka, C. Abad Zapatero, S. G. Franzblau, F. Movahedzadeh. Structure of the Fructose 1,6-

•

bisphosphatase (II) from M. Tuberculosis: Insights into target based drug discovery. National Biotechnology

Conference, San Diego. May 2012 (Poster).

Abad-Zapatero C., Gutka H.J., Franzblau S.G., Movahedzadeh F. Structural Characterization of glpX

•

encoded Fructose 1,6 - bisphosphatase. IUCr International congress XXII, Madrid, Spain August 2011

(Poster).

Gutka H.J., Franzblau S.G., Abad-Zapatero C. Movahedzadeh F. Enzymatic and Preliminary Structural

•

Characterization of glpX encoded Fructose 1, 6 – bisphosphatase from M. tuberculosis. Keystone symposia

(J4) Mycobacteria: Physiology, Metabolism and Pathogenesis - Back to the Basics. Vancouver Canada Jan

2011 (Poster).

Tuberculosis research - a graduate student’s perspective, at Harold Washington College (City College of

•

Chicago) May 2010 (Podium).

Gutka H.J., Franzblau S.G., Abad-Zapatero C., Movahedzadeh F. Biochemical characterization of glpX

•

th

(Rv1099c) encoded Fructose 1,6 – bisphosphatase from Mycobacterium tuberculosis. 48 Annual MIKI

meeting at University of Illinois at Chicago. April 2010 (Poster).

Gutka H. J., Gavit R.S., Laddha K. S. Formulation and HPTLC based standardization of whole leaf Aloe

•

vera juice. International Conference on Botanicals, Jadhavpur University School of Natural Products,

Calcutta 2005 (Poster).

Gutka H. J., Gavit R.S., Laddha K. S. Simultaneous Quantitative estimation of Benzoic acid and Sorbic acid

•

th

in Aloe vera gel by HPLC, 56 Indian Pharmaceutical Congress Calcutta 2004 (Podium).

Professional Memberships and Certifications

Indian Pharmaceutical Association Maharashtra State Branch. (IPA MSB)

Registered Pharmacist The Pharmacy Council of India Maharashtra State Branch. (PCI-MSB).

American Association of Pharmaceutical Scientists (AAPS)

American Crystallographic Association (ACA)

Post Graduate Diploma in Pharmaceutical Management: University of Pondicherry 2004

Post Graduate Diploma in Intellectual Property Rights; Bioinformatics Institute of India 2006.

Contact this candidate