Development Quality
Resume:
HITEN JAYANTI GUTKA
#G-*, **** Anderson Road, Oxford, MS-38655. Email: *********@*****.*** 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.
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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
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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.
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Gutka H. J., Laddha K. S. An insight into Aloe vera Part II, Chemical Weekly August 2004.
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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.
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