Quality Control Manufacturing

Objective: Seeking a Quality Control Microbiologist or Assurance position where I can apply my broad range of cGMP and cGLP experience.

SUMMARY

6+ years of experience in the field of Quality control & Assurance in Pharmaceuticals Microbiology for Sterile & Non-Sterile Testing.

MS in Molecular Biology and Microbiology (University of Central Florida, Orlando) and MS in Biotechnology (University of Abertay, Scotland).

Currently working in cGMP regulated environment with cGLP documentation skills.

Able to work independently and in Team work in highly regulated environment.

FDA and EU regulations knowledge of Environment monitoring of clean Rooms and Purified water systems

Clean Room Training evaluation and certification of aseptic techniques for employees to work in ISO 5 and 7.

Working Knowledge of 21 CFR 210 and 211and USP related to microbial testing and 21CFR 820 quality system regulations.

Change controls, CAPA, Investigations, Planned and unplanned deviations.

ICH Q6, ICH Q7, ICH Q8, ICH Q9 requirements and Quality system review

Knowledge on Investigations relating to out of specifications relating to raw materials, excipients and finished products, environment monitoring biological indicators, high purity water systems.

Need H1B visa transfer.

EDUCATION

Masters in Molecular Biology and Microbiology, University of Central Florida, Orlando; GPA 3.95/4.0; Mentor: Prof. Steven N. Ebert

oProject: Generation of recombinant mouse embryonic stem cell lines and their application for in vivo bioluminescence imaging in the heart

Masters in Biotechnology, University of Abertay, Dundee, Scotland

oProject: Micro protoplast technology in potato

BSc., Acharya N.G.Ranga University, Hyderabad, India

WORK EXPERIENCE

Pharmaceutics International Inc., MD April 2011 – Current

(Non- sterile oral dosage, capsules and parenteral drug products)

Role: Quality control Microbiologist,

Responsibilities:

Support Environmental Monitoring Program grade A through C manufacturing for aseptic parental production areas as well as oral dosage and softgel manufacturing.

Prepare Microbiological/water systems trending data in suitable format for internal and external quality reviews and regulatory audits.

Support and execute endotoxin validation studies of manufacturing such as depyrogenation tunnels, vial washers, method development and release testing.

Liaising with other departments to determine microbiology testing resource requirements and associated project planning

Training Junior Analysts and requirements includes USP <51>, <61>, <62>, <71>, <85> and others.

MLT release Testing and Validation.

Preservative efficacy suitability and release testing.

Sterility testing Method Suitability Membrane filtration and direct Inoculation

Pharma water sampling and TOC, conductivity and bioburden testing.

Container closure testing for vials using dye ingress studies.

Cleaning verification hold time studies.

Media fill simulation studies for vials and syringes.

Writing and Execution of protocols, SOPs.

MD Anderson Cancer Research Center, Nov’ 2010 – Mar’ 2011

Orlando, FL

Role: Senior Research Technician

Detection of Mycoplasma engineered proteins in prostate cancer cell lines using western Blots and immunostaining.

NeoCytex Biopharma, Inc., FL Aug’ 2008 – Oct’ 2010

Role: Research Associate in Biology

Responsibilities:

Cell culture optimization, including difficult-to-grow primary cell lines, embryonic stem cells, neural stem cells, cancer stem cells, and cardiomyocytes.

Molecular biology, including molecular cloning, real-time PCR, electroporation

Antibody technologies, including microimaging, immunohistochemistry, immunofluorescence and confocal microscopy

Protein analysis and separation methods

Animal microsurgery and transplantation (brain, cardiac)

Use of rodent models of diseases (Stroke, Parkinson’s; cardiac diseases)

In vivo optical imaging

Data analysis, biostatistics, and presentation software (including MS Office

Study of factors that influence neural stem cell proliferation and lineage

Evaluated the neuroregenerative effects of a drug candidate in rodent models of stroke and Parkinson’s disease: Quantified the dose-dependent activity of the compound using immunohistochemical and immunoblotting techniques.

Initiated a project to identify glioblastoma tumor stem cell markers: Identified a novel marker in tumor cells with a team isolated from human donor-derived tissues (our two posters were among the award winners at the International Brain Conference, 10/09)

University of Central Florida, Orlando Jan’ 2005 - Aug’ 2008

Development Cardiology Lab,

Graduate Studies and Research Associate

Generation of recombinant mouse embryonic stem cell lines and their application for in vivo bioluminescence imaging in the heart

oPrepared three novel cell lines expressing luciferase reporter gene under the control cardiac specific promoters; cells were used to study survival, proliferation and differentiation in animal models

oFollowed the fate of transplanted luciferase-expressing cells, in vivo, by noninvasive bioluminescence imaging

Generation of cardiomyocytes from pluripotent mouse embryonic stem cells

oEvaluated of factors that influence cardiac differentiation

oLarge scale isolation of stem cell-derived cardiomyocytes for transplantation

PUBLICATIONS AND PRESENTATIONS

Soumya chigurupati, Arinama Bhasin,Krishna kishore Inampudi, Swapna Asuthkar, bhanupriya madarampalli,Raman Kumar Kammili, Kirankumar Velupala

Functional and structural analysis of mice TRPC6 with human analog through homology modeling International Journal of bioinformatics Research and applications 2012

Kammili RK, Taylor, DG, Xia, J, Osuala, K, Thompson, K, Menick, DR, Ebert, SN. Generation of novel reporter stem cells and their application for non-invasive molecular imaging of cardiac-differentiated stem cells in vivo. Stem Cells and Development, Published (01/28/2010).

Presentations/posters:

Kammili RK, Dantuma, EM, Field, M, Bushnev, S, Sugaya, K. Identification of novel stem cell marker in glioblastoma tumor initiating cells.

Alvarez, A.,Kammili RK, Dantuma, EM, Field, M, Bushnev, S., Avgeropoulos, N, Sugaya, K. Immunocytochemical analysis of markers distinguishing tumor stem cells from normal human neuronal stem cell populations in glioblastoma multiforme. International Brain Conference. Orlando, FL. 2009.

Kammili RK, Dantuma, EM, Alvarez, A.,Field, M, Bushnev, S., Avgeropoulos, N, Sugaya, K. Gene expression analysis of markers distinguishing tumor stem cells from normal human neuronal stem cell populations in glioblastoma multiforme. International Brain Conference, Orlando, FL. 2009.

Kammili RK, Taylor, DG, Thompson, K., Ebert, SN. In vivo molecular imaging of cardiac-differentiated cells in mouse heart. UCF Showcase Presentation. 2009.

Kammili RK, Taylor, DG, Thompson, K, and Ebert, SN. Non-invasive in vivo cellular and molecular imaging of transplanted stem cells for cardiac repair/regeneration strategies using magnetic resonance and bioluminescence modalities. Weinstein Cardiovascular Conference. 2008.

Kammili RK, Taylor, DG, Thompson, K, and Ebert, SN. Development of novel cellular and molecular tools for in vivo bioluminescent imaging in heart. Weinstein Cardiovascular Conference. Indianapolis, IN. 2007.

REFERENCES

1.Dr. Steve N Ebert

Associate Professor

Coordinator, Biomedical Sciences Ph.D. Program

BMS 321

Phone: 407-***-****

Research Area: Cardiovascular E-mail:******.*****@***.***.

2.Nilabh Chaudhary, PhD

CEO and Director of R&D

NeoCytex Biopharma, Inc.

632 Russell St.

Covington, KY 41011

Phone: 513-***-****

E-mail: **********@********.***

3.Pradeep Puppana,

Pharmaceutical international Inc.

Phone: 253-***-****

E-mail: ********@******-***.***

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