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Shravan Kumar Gattu

Gaithersburg, MD 20878

Phone- 443-716-5142 Email- shravangattu2481@gmail.com

Summary:

Over 8 years of experience working in research and development of biopharmaceutical industry. Currently, I am undergoing training in business intelligence and skills to serve the broader needs of the industry.

Expertise in liquid and Lyophilized formulation development of Drug product and Drug substance, stability and fill-finish as per ICH guidelines.

Experience with wide variety of molecules such as RSV, FLU nanoparticle vaccines, monoclonal antibody, Fc fusion, Fab, peptide, and ADC.

Developed formulation concentrations ranging 0.045 µg/mL to 150 mg/mL.

Strong work ethic and active collaborator.

Two Master’s from University of Dundee (Research in Cancer Biology) and Sheffield Hallam University (Pharmacology and Biotechnology).

Familiar with FDA, ICH, and European regulations.

Good understanding of IND, BLA, and MAA regulatory sections.

Technical Expertise:

PFS Device development, process scale-up and technology transfer

Strong analytical characterization and validation skills in modern techniques such as chromatography separation (HPLC-SEC, RP-HPLC, HIC, Affinity chromatography)

Spectroscopy- [UV-Visible, DLS (Dynamic light scattering), DSLS (Differential static light scattering), Fluorescence (PTI), CD and FTIR]

Calorimetry-TA-DSC (Differential scanning Calorimetry), MicroCal DSC, ITC

Thermo cycler- DSF.

SDS-PAGE electrophoresis, Capillary electrophoresis, ELISA assay (Immunology technique- Immunocytochemistry), SRID (Single Radial Immunodiffusion), NAA (Neuraminidase Assay), blotting of protein (Western blotting) and lipid blot assays.

Solid and Liquid phase extraction

MFI (Micro flow Imaging-Protein simple) and HIAC (9705).

Lyophilization-SmartLyophilizer freeze drying system

Viscosity-Rheometer (Anton-Paar)

Freezing-Bio cool controlled rate freezer and Celsius S3 systems

Functionality testing-Instron 5542

TFF (Tangential flow filtration) Scilog pure Tec

Freezing point Osmometer and Vapor pressure Osmometer

Aseptic handling techniques (BSC).

Microscopy- Freeze-dry, light microscope, fluorescence microscope.

Molecular/Cell biology techniques such as expression cloning (PCR, restriction digestion, Ligation), gene transfer (transformation, transfections), protein expression and purification.

Additional Skills

Project management, Management, Talent management

Coaching, Mentoring,

Communication

Teamwork, Decision making, Design thinking

Leading meetings and Leadership

Writing articles

Life skills.

Statistics, Data Analysis

Software

Proficient in MS Office applications, LIMS, JMP statistical software, SAS, sigma plot, volocity and origin data analysis software. Interpersonal

Practice work ethics, well rapport with fellow scientists and good coordination with team members. Organizational skills Meticulous organization skills such as maintaining detailed documentation, meeting the priorities and executing new projects.

PROFESSIONAL EXPERIENCE:

Trainee at Lynda.com

May 2016- Present

Working on improving Business skills and Intelligence with certifications at Lynda.com

Formulation Development Associate II (NOVAVAX) Sep 2015 Apr 2016

Worked on FLU (Phase II) and RSV Nanoparticle vaccine (Phase III) formulations at concentrations 150 & 270 µg/mL.

Role and Responsibilities: Design of studies, Conducting stability studies as per ICH guidelines, writing protocols for the study, following protocols strictly with minimal variability, generating data in the lab, analyzing the data, creating excel templates for the study for easy data input and also presenting data at various meetings.

R&D Associate II-Formulation Sciences MedImmune LLC (Astra Zeneca)

July 2013- Sep 2015

Worked on

Fusion proteins and specifics

work for

 

developing platform formulation

 

Supported Fab formulation development work indicated in treating cardiovascular complications (lyophilization, formulation screening). Developed a formulation with recon time less than 30 minutes.

Worked on the clinical compatibility of ADC (Antibody drug conjugate) which resulted in IND (Investigational New Drug) submission.

Worked

on

low

Tg’

lyophilized

formulations

for

better

cake

appearance

and

porosity

(Publication accepted)

 

Initiated phase II studies for the formulation development of bispecific molecule (Fc fusion) indicated in alleviating neuropathic pain (pH screen, excipient robustness, Concentration of protein, Freeze-thaw, and surfactant concentration bracketing). Developed a low protein concentration liquid formulation (0.045 µg/mL) suitable for a device such as PFS (Pre-filled Syringe).

Conducted drug product configuration stability studies (fill volume and protein concentration bracketing) and clinical compatibility studies for a mAb in phase III indicated in treating SLE (Systemic Lupus Erythematosus). Currently conducting PFS development studies, including

long-term stability, silicone, and tungsten compatibility studies. Developed an Ultra Concentrated Liquid Formulation (150 mg/mL) with novel excipient as a viscosity modifier for PFS device (patent). Monitored structure/function assessments of stability samples by characterizing Higher ordered structure (HOS) by HPLC (SEC).

Initiated non-GLP tox in-use stability studies for a fusion molecule.

Conducted a formulation composition DOE for selection of a robust liquid formulation for a bispecific molecule.

Drafted and completed development reports and clinical compatibility reports and experimental protocols for all studies conducted.

Role and Responsibilities: Design of studies, Conducting stability studies as per ICH guidelines, writing protocols for the study, following protocols strictly with minimal variability, generating data in the lab, analyzing the data, creating excel templates for the study for easy data input and also presenting data at various meetings

R&D Associate -Formulation Sciences

MedImmune LLC (Aerotek),

Dec 2012 July 2013

Initiated and executed multiple stability studies in support of high and ultra-high concentrated liquid protein therapeutics for mAb indicated in treating SLE (Phase III) both accelerated and long-term studies.

Assessed and compared stability profiles of a mAb for selection of process development of mAb.

Utilized multiple assays in house (Formulation Sciences) and also submitting for analytical testing for monitoring mAb stability and purity characterization by HPLC (HPSEC) and fragmentation analysis by RP-HPLC.

Monitored sub-visible particles with Micro flow imaging (MFI) and HIAC.

Assisted in fill-finish operations of prefilled syringes and vial liquid formulations.

Characterized viscosity of high concentrated liquid formulations and density profiles such as concentration vs. density of a mAb.

Assisted in the initiation of forced degradation studies with metal spiking, robustness studies on formulation excipients.

Performed diafiltration (TFF) for buffer exchange of high volume protein solutions.

Role and Responsibility: Understanding the written protocol, following the protocol strictly, generating data in the lab, transferring data to the excel templates, perform data analysis and present the data at meetings

Special Volunteer - Department of Biochemistry, National Cancer Institute, NIH. Aug 2012- Nov

2012

Worked on a telomere capping project, Yikang’s lab discovered that a TEA protein forms a complex with two other proteins STN and TENG to protect the telomere end part. TEA protein was expressed in sf9cells and gene related to TEA was amplified in bacmids using recombineering techniques developed by Yikang Rong lab.

Cloning of genes into plasmids, bacmids by recombinant engineering, thermal cycler (PCR) for amplification of genes

Preparation of competent cells (sw102 cells) for transformation, protein expression in insect cells (sf9 cells), and SDS-PAGE gel electrophoresis for analysis of protein expression.

Research Trainee

University of Dundee

Jan 2011- Aug 2011

Worked on a project titled “Identification of highly selective and low-affinity phosphatidyl inositol (3,4,5) phosphate binding proteins”. The outcome of the project was new binding proteins (FGD6- PH1A, IRS1-PH1A) with pleckstrin homology domains (PH domains) were discovered.

Purification of proteins and performed lipid- protein binding analysis by biophysical technique such as SPR (surface Plasmon resonance), analyzed protein concentration by Bradford assay by UV-Visible spectrophotometer and also characterized proteins by SDS-PAGE (Nu-PAGE gels) gel electrophoresis, performed dialysis for concentrating proteins, maintained records, performed data analysis and presented data in lab meetings.

Research Associate- Department of Neuroscience, University of Dundee Jan 2009 - July 2010 Worked on a project titled “Endocytotic signaling of 5-Hydroxy tryptamine (5-HT3A/B) receptors”. Project outcome was the work was submitted to Journal of Biological chemistry (JBC) (still ongoing).

Cloning of genes into plasmids for protein expression, performed site-directed mutagenesis for studying the behavior of mutant recombinant proteins by Fluorescence microscopy and Fluorescence spectroscopy, utilized monoclonal and polyclonal antibodies for various ELISA assays, optimized protein expression and applied different chromatographic (affinity chromatography) techniques for separation of proteins, characterization of proteins from a pool of cellular proteins by SDS-PAGE (Nu-PAGE gels), Cell culture/ tissue culture, maintained up- to-date lab notebook, performed data analysis and presented data in meetings.

Research Assistant

Worked on a project titled “NCS-1 (Neuronal calcium sensor-1 proteins) signaling in ataxia”.

University of Sheffield

Jan 2008 Dec 2008

Preparation of primers for PCR amplification of genes, protein purification by affinity chromatography of recombinant proteins, maintained records and performed data analysis.

Project Student Sheffield Hallam University Jun 2007- Aug 2007 Worked on a project titled “HPLC separation of vitamin E, retinol, Carotenoids and their detection at various wavelengths by UV-DAD (Diode array detector). Project outcome was developed a new method for routine lab analysis of multivitamins.

Developed a robust method for the routine lab analysis using reverse phase HPLC systems, for separation and identification of the antioxidant vitamins from multivitamin capsules with UV- Diode array detector.

Project student

Worked on a project titled “Mandatory vaccination of viral hepatitis B for last minute travelers”.

Project outcome made recommendations for vaccination of 3 doses.

Advocated the mandatory vaccination for hepatitis B and benefits of vaccine for last minute travelers. Did an extensive literature search for studying immunization response of vaccine in different populations and recommendation of minimum 3 doses for a good immunization response to combat hepatitis B.

Sheffield Hallam University

Mar 2007- Jun 2007

Junior Analyst- Quality Control Lab, Virchow Labs May 2004-Apr 2006 Worked in quality control lab on Sulfamethoxazole (bacteriostatic antibiotic-veterinary medicine) exported to Europe.

Analysis of raw materials and excipients by HPLC (reverse phase), detection of impurities of raw materials by FTIR spectroscopy, analysis of intermediate and finished product, characterization of particles by particle analyzer (Master sizer), checking the total organic content (Total organic carbon), performed moisture analysis by Karl Fisher titration, checking the concentration of the materials by UV-Visible spectrophotometer, maintaining records as per cGMP procedure, reporting and troubleshooting the problems, performing data analysis and presenting data in group meetings.

EDUCATION and TRAINING:

Degree

Master of research (Cancer Biology) University of Dundee, UK Aug 2010- Sep 2011 Thesis Title: “Identification of highly selective and low-affinity phosphatidyl inositol (3, 4, 5) phosphate binding proteins”.

University

Date of Completion

MSc Pharmacology & Biotechnology Sheffield Hallam University Sep 2006-Aug 2007 Thesis Title: “HPLC separation of Vitamin E, Retinol and Carotenoids and their detection at various wavelengths by U.V (Diode Array Detector)”.

Bachelors in Pharmacy Hyderabad, India

Sri Venkateswara College of Pharmacy, Osmania University, Jun 2000-Jul 2004

Research Trainee

Training- Underwent training in HPLC systems for method development and trouble shooting.

LASERCHROME Labs

Sep 2007- Dec 2007

Publications “Effect of Freezing on Lyophilized Drug Product Cake Appearance, Journal of Pharmaceutical Sciences, 2015”.

Registration Registered pharmacist in India

Certification Base SAS certification

AWARDS AND FELLOWSHIPS Awarded prestigious University of Dundee scholarship (£3000) for MRes in Cancer Biology

2010/2011.

REFERENCES Provided upon request