Project Quality Control

EXPERIENCE

I am a Biochemist with ** + years of hands on bench work experience in Biotech industry and academia. Proven problem solving, data analysis/quality control, protocol writing, editing and mentoring skills. I also possess excellent communication skills in coordination of cross-functional teams. Excellent knowledge of cGMP, GLP, Product Process Development and Process, Assay, Material and Cleaning Validations.

Baxter Healthcare Corporation, Thousand Oaks, CA 2014-May 2015

Sr. Validation Engineer, Contractor

•Worked on Material Qualifications for Advate project (Recombinant, lyophilized, Factor VIII)

•Wrote and executed Material Qualification protocols and reports. Conducted and lead Risk Assessments and FMEA cross functional meetings, Quality Impact Studies and coordinated internally, globally with multi-departmental activities and with external vendors. Executed the qualification of reconstitution device, Baxject III with the Advate container closure system.

•Conducted assessment of IQ, OQ, PQ and Extractables/Leachables studies for materials for their compatibility with the Advate process.

•All the validation studies were conducted in compliance with cGMP, QSR, GLP and ISO regulations.

Baxter Healthcare Corporation, Los Angeles, CA 2011- 2013

Research Associate II, Contractor

•Worked as a member of the Process Development team on the Monoclonal Antibody (MAb) 0702 resin conversion project (Hemofil-M), for purification of Factor VIII (AHF-M) from plasma. Executed the project which involved, process validation, protein purification, troubleshooting, assay validations, management of sample testing and raw material inventory for the project

•Completed the project 4 months prior to the deadline which resulted in a savings of millions of dollars for the company

•Trained and qualified contractors and Baxter employees on Process Optimization, ELISA and Affinity chromatography (FPLC) using AKTA Avant (Unicorn 6.1 and 6.2) and AKTA Explorer, ensuring continuity and smooth functioning of the project. Good knowledge of 21CFR11, 21 CFR 210 and 211.

•Completed the cleaning validation study of Millipore’s Quikscale column. Participated in IQ/OQ/PQ of lab equipment.

•Wrote and reviewed protocols, URS, FS, DS, conducting feasibility, data analysis and validation studies using ELISA and Siemens’s Behring Nephelometry under different matrices.

•Knowledge in Change Control, Risk analysis, Lean principles, QSR, CAPA, QbD, MS Sharepoint, MS Project and DoE.

CIRM Bridges to Stem Cell Research Internship 2009-2010

Characterization of Human Embryonic Stem Cells

Mentor: Director, Prof. Martin F. Pera, USC

•Maintained and analyzed seven human embryonic stem (hES) cell lines

•Established protocol for G-banding and Spectral karyotyping. Responsible for sample preparation and testing

•Tested the effect of ascorbic acid on CD30 expression of hES cells. Protein purification and

characterization conducted by Immunostaining, qPCR, SDS-PAGE and Western blotting.

•Trained in Laboratory safety and Fluorescence Flow cytometry.

•Presented research findings at the CIRM meeting in July 2010 on my research project

Codexis Inc., Pasadena, CA 2007-2008

Research Associate, Quality Control

• Responsible for quality control, stability testing, sample preparation, protocol testing, validation and downstream-processing of all the recombinant enzymes being manufactured in a lyophilized state. Responsible for tracking and maintaining chemical inventory. Enzyme characterization done using SDS PAGE.

•Improved quality and reproducibility by optimizing the bulk Cytochrome P450 (MicroCYP) QC assay methods (HPLC and Dual beam Spectrophotometer).

•Successful in method development of new enzymes being introduced, conducted troubleshooting and validation of all the instruments being used for QC

•Facilitated the introduction of MicroCYP screening plates before deadline, helped the company by lowering production costs by at least 10%

•Increased the efficiency of the QC department by 50% by implementing high-throughput and parallel QC assay techniques

Oak Crest Institute of Science, CA 2005-2006

Research Associate

•Worked independently on a project using environmental isolates for bacterial sulfoxidation of pro-chiral sulfides.

• Responsible for identifying, biochemical characterization and sequencing of the bacterial isolates.

•Initiated bacterial sequencing work. Responsible for sample preparation.

•Isolated at least three bacterial strains capable of utilizing thioanisole as a sole source of Carbon.

•Co-authored paper published in May 2009 to BioMed Central Microbiology, titled, “Characterization of Structures in Biofilms Formed by Pseudomonas fluorescens Isolated from Soil”. http://www.biomedcentral.com/1471-2180/9/103.

•Presented of my research findings at American Chemical Society Conference in September 2006.

MET’S Institute of Pharmacy 1994-1998

Lecturer

•Initiated and conducted academic courses and labs in Biochemistry, Microbiology and Clinical Pathology for a class of 30+ Pharmacy students.

•Established Biochemistry, Microbiology and Sterility Testing laboratories.

•Selected as an Examiner by the University

EMD Pharmaceuticals 1987-1992

Supervisor, QC (Pharma)

•Performed and supervised Microbiological and Chemical analysis as well as OOS investigation, sampling and stability studies of pharmaceutical products and raw materials as per USP, EU and IP guidelines. Responsible for sample preparation. Increased efficiency of the department by at

least 20%.

•Implemented GMP/GLP in manufacturing and Quality Control Laboratory.

•Mentored and managed 4 analysts ensuring consistency in quality of testing.

Qualified as Certified Chemist by FDA (India) for Sterility testing and Microbiological analyses

EDUCATION

•M.S. (Biochemistry), University of Mumbai, India, (GPA: 3.94)

•B.S. (Biochemistry and Microbiology) University of Mumbai, India

•Certificate course in Biological Technology and Stem Cell Culture: Pasadena City College, CA

•Certificate courses in Microsoft Word, Excel, and Power point

•Certificate courses in Oracle, SQL, Front page, XML, C, C++, Core Java

•Actively looking into starting PMP certification.

OUTREACH/ACTIVITIES

•Committee member and Treasurer of Boy Scout Troop 342, Responsible for the Chemistry Merit badge for the Scouts and annual fundraising activities for the troop, raised at least $15,000 annually, for the last 3 years.

•Actively involved in fundraising activities for the American Cancer Society.

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