Senior Bioanalytical Scientist

BIOANALYTICAL CHEMISTRY / BIOCHEMISTRY LABORATORY PROFESSIONAL

Success through Personal Leadership and Technical Experience

PROFILE

Experienced Senior Bioanalytical Scientist with a strong track record of performance in Pre-Clinical Drug Development. Possesses extensive hands-on laboratory experience, an exceptional work ethic and a commitment to meeting organizational objectives for accuracy, efficiency, and cost-effectiveness. Utilizes a high level of technological proficiency, flexibility, and a strong understanding of current Good Manufacturing Practices (cGMP) to deliver results.

Hard working, conscientious professional who maximizes cost effectiveness, utilizing excellent problem solving capabilities, including acquisition of assays for in-house lab and development of new assays. Scientist skilled in assay development, enzymology, molecular biology, and bioinformatics.

CORE COMPETENCIES

Bioanalytical Chemist• Biopharmaceuticals/Biologics (monoclonal antibodies, cytokines, immunotoxins, peptides)•

In-process Materials• Finished Products• Customer Service• Test procedures and Protocol Development• Regulatory Standard Compliance• Equipment Specification• New Technology Evaluation• Technical Report Preparation and Presentation• Project Management• Audits/Validation• Standard Operating Procedures (SOP)• Out of Specification Investigations (OOS) - CAPA Procedures (Identification, Evaluation, Investigation, Analysis, Action Plan, Implementation, and Follow up)• Current Good Manufacturing Practices (cGMP)• Assay Development - BIAcore, FACS, SEC-HPLC/MALS, DLS, CE, DSC, ELISA, SDS-PAGE, Western, UV-Vis Spectroscopy, CD Spectroscopy.

PROFESSIONAL EXPERIENCE

09/2001 - 12/2011

Development Scientist III, Process Analytics, Biopharmaceutical Development Program (BDP)

SAIC-Frederick, Inc., Frederick, MD.

Pre-Clinical Development of Biologics:

• Developed and executed bioanalytical methods to determine therapeutic quality (identity, purity, stability, and potency) of biologics during late stage product optimization efforts.

• Ensured the on time delivery of critical material for clinical trials (non-pivotal phase III

for neuroblastoma) in multiple medical centers in United States and Canada by the timely development, completion, and oversight of multiple assays for multiple lots of a monoclonal antibody.

• Developed and delivered two peptide vaccines (2gram each) in final formulation buffer with and without CpG adjuvant for Phase I dose escalation studies (Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants. http://clinicaltrials.gov/ct2/show/NCT00722839).

• Evaluated interim process samples, drug substances, and product produced by third-party to determine product comparability and best assay methods in critical path of project transfer to third-party.

• Developed a BIAcore based binding assay to confirm the identity and specificity of an immunotoxin under evaluation for the treatment of a specific type of brain tumor.

• Collaborated and reviewed a PK study that determined the cardiovascular effect of salt, pH, counter-ions (TFA or acetate), and excipients in the formulation buffer of a potential drug.

• Conducted analyses and validation of medical devices (Gene-gun containing gold chelated DNA vaccine against Human Pappiloma Virus) to determine their safety, efficacy, and stability.

• Developed and evaluated the accuracy, precision, or reliability of new protocols for product development using parameters like system suitability controls, assay controls, limit of detection (LOD), limit of quantitation (LOQ) and standard curves.

• Worked with internal teams and Quality Assurance (QA) to successfully achieve GMP compliance as well as safety of medical devices and products.

01/1998 - 09/2001

Staff Fellow, Section of Histopharmacology, NIMH, NIH.

• Performed highly independent research in the area of molecular biology and protein chemistry.

• Identified, cloned, and characterized a point mutation in a calcium binding protein, calretinin, present in mesothelioma cells. Performed in vitro phosphorylation studies as well as molecular modeling studies were performed to characterize the WT and mutant proteins.

• Differential display along with RT-PCR, DNA sequencing, cloning, and Bioinformatics was used to identify an alternatively spliced variant of a caveolae associated protein, Flotillin-1, from frozen Parkinson’s disease brain sample. Brain localization of this particular protein was accomplished thorough in situ hybridization histochemistry.

• Developed a 2-D gel electrophoresis protocol for characterizing proteins present in various brain samples and is currently in use at Center for Molecular Medicine at Uniformed Services University, Bethesda, MD.

• Developed a database to combine the molecular and clinical patient data.

• Trained and mentored students and technicians.

02/1994 - 12/1997

Post-doctoral Fellow, Section of Molecular Biology, NIAAA, NIH.

• Purification and characterization of enzymes (pyruvate dehydrogenase complex).

• Cloning, expression, purification, and characterization of recombinant enzymes from bacteria and baculovirus expression systems; mutagenesis using PCR.

• Homology molecular modeling of enzymes (e.g. transketolase) and G-protein coupled receptors (e.g. serotonin receptor 1A1); founding member of the NIH Molecular Modeling Interest group.

EDUCATION

Ph.D. Bioorganic Chemistry / Biochemistry University of Maryland, College Park, MD.

Thesis: Mechanistic Studies of Mandelate Racemase by Site Directed Mutagenesis.

Master of Science, Chemistry University of Kerala, India.

Bachelor of Science, Chemistry University of Kerala, India.

PROFESSIONAL DEVELOPMENT

Extensive additional education including Management Development Program, How to Coach Your Employees, Achieving and Maintaining Laboratory cGMP compliance, Quality Control and Quality Assurance of Biotechnology Products, Regulatory Issues in Biotechnology, Analytical Method Validation, Advanced Training in BIAcore at GE with Certification, and Advanced Training in Multi Angle Light Scattering (MALS) at Wyatt Corporation with Certification.

PROFESSIONAL RECOGNITION (Partial)

YEAR END RECOGNITION (2010): "Outstanding performance in the development and execution of BIAcore Assays for different projects independently with minimum technical advice."

YEAR END RECOGNITION (2009): "Outstanding performance in managing and coordinating

the peptide project and bringing it to a conclusion."

YEAR END RECOGNITION (2008): "Outstanding performance in both analytical support and management of the peptide project."

PUBLICATIONS (Full list available on request)

1. Soman G, Kallarakal AT, et.al (Volume 4, Issue 1 Jan/Feb 2012. Molecular Antibodies)

Analytical characterization of ch14.18: A mouse-human chimeric disialoganglioside-specific therapeutic antibody.

2. Jacobowitz DM, Kallarakal AT.

Flotillin-1 in the substantia nigra of the Parkinson brain and a predominant localization in catecholaminergic nerves in the rat brain Neurotox Res 6 (4): 245-257 (2004).

3. Schafer SL, Barrett WC, Kallarakal AT, et al.

Mechanism of the Reaction Catalyzed by MandelateR: Structure and P of the D270N Mutant Biochemistry-US 35 (18): 5662-5669 MAY 7 1996.

4. Mitra B, Kallarakal AT, Kozarich JW, et al.

Mechanism of the Reaction Catalyzed by Mandelate Racemase - Importance of Electrophilic Catalysis by Glutamic-acid-317 Biochemistry-US 34 (9): 2777-2787 MAR 7 1995.

5. Kallarakal AT, Mitra B, Kozarich JW, et al.

Mechanism of the Reaction Catalyzed by Mandelate Racemase - Structure and Mechanistic Properties of the K166R Mutant Biochemistry-US 34 (9): 2788-2797 MAR 7 1995.

6. Landro JA, Kallarakal AT, Ransom SC, et al.

Mechanism of the Reaction Catalyzed by Mandelate Racemase .3. Asymmetry in Reactions Catalyzed by the H297N Mutant Biochemistry-US 30 (38): 9274-9281 SEP 24 1991.

PRESENTATIONS (Full list available on request)

1. Kallarakal AT, et.al., Spring Research Festival, NCI, Fort Detrick, Frederick, MD. April, 2010. BIAcore Assay Development: Addressing the Binding Specificity.

2. Kallarakal AT, et.al., Spring Research Festival, NCI, Fort Detrick, Frederick, MD. April, 2008. Lectin-Carbohydrate Interaction: A BIAcore-based Assay Development.

3. Kallarakal AT, and D.M. Jacobowitz. Neuroscience Meeting, San Diego, November 2001.

Flotillin-1 and a Deletion Variant in the Substantia Nigra in Parkinson's Disease.

4. Kallarakal AT, A.M. Rowland, and D.M. Jacobowitz. NIH Research Festival, October 1999. Novel Role for Calretinin, a Calcium Binding Protein: Modulation of Casein Kinase II Activity.

Contact this candidate