Scientist 1 (QA/QC)

Vaishali Sarode

*** **** ****** *********, *** **1, San Jose, CA 95123

(C) 617-***-**** (E) **************@*******.***

Professional Overview

Over 3 years of experience in research and quality control in a cGMP environment

Best known for abilities in cell based assays, process development and auditing

Accomplishments

Bio assays : Cell based assays subject matter expert

Quality Systems: Identified problems and provided solutions to expiration dating system

in Enterprise 1 systems thereby reduced cost, labor by 20% and an increase in quality

Certified as an Lead Internal Auditor with Medical Device Focus ISO13485:2003

Employment History

Scientist I (Quality control/Assurance) 2010-Present

Life Technologies (Carlsbad, CA) is a global biotechnology tools company dedicated to improve

the human conditions with innovative life science products

Expertise in developing, validating and performing proliferation, cytotoxicity and

chemotaxis assays for testing recombinant proteins

Proactively contributed to stability program by trending past data, grouping products by

families and testing type resulting in 90K and above cost savings

Improvised existing standard operating procedures (SOP) by clarifying test steps with

diagrams, making it more user friendly and thereby reducing repeat testing and cost

Created, reviewed and approved quality product specifications of recombinant proteins by

reviewing, analyzing past records and in collaboration with quality

Collaborated in smooth transfer of new methodology and products from manufacturing

sciences, thereby help launch new products in the market on time

Trained new hires in identifying faulty expiration dating in the system thereby increasing

quality

Expertise in Immunohistochemical tests of raw materials, intermediates and finished goods

of the flagship breast cancer detection kit like CISH

Graduate Research Assistant 2008-2010

Northeastern University, Boston, MA

Worked under the able guidance of Dr Akio Ohta at New England Inflammation and Tissue

Protection Institute in the field of Cancer Immunology

Project: Deciphering the role of Adenosine in tumor development using lymphocytes

Conducted flow cytometry analysis of splenic T-cells by staining with fluorescent

conjugated antibodies (FITC) in order to identify the genetic sequence of the mice

Performed T-cell proliferation assays by stimulating isolated cells with anit-CD3

antibody and labeling them with an isotope [3H] thymidine in order to measure in

immunological response of the knockout mice

Project: Percentage of incorporation of drug in liposomes

Analyzed the percentage of incorporation of the drug via high performance liquid

chromatography (HPLC) by designing experiments and literature survey, in order to

evaluate the efficiency of incorporation of the drug doxorubicin

Education

Masters of Science: Pharmaceutical Science, Northeastern University, Boston, USA

Relevant courses: Biochemistry, Molecular Biology, Bioethics, Anatomy & Physiology,

Biomedical chemical analysis, Pharmacokinetics & drug metabolism

Bachelor of Science: Pharmacy, University of Pune, India

Relevant courses: Pharmaceutics, Pharmacology, Microbiology, Analytical Chemistry,

Organic Chemistry, Medicinal Chemistry, Pharmaceutical Analysis, Bio pharmaceutics

Skills Profile

Assays: Cell-based assays such as Proliferation, Cytotoxicity and Chemotaxis

Molecular Biology techniques: DNA purification, PCR, cDNA synthesis and RNA

isolation, ELISA, Endotoxin (LAL),Mycoplasma testing, Fluorescence microscopy,

Immunoassays, Confocal Microscopy, cell culture, cryopreservation

Flow cytometry analysis

Immunohistochemistry : Tissue sectioning and staining,

Quality Assurance: ISO13485, 21CFR 820, FMEA Analysis, CAPA, Batch record review

Office Tools: Microsoft office (Word, Excel, PowerPoint, Outlook)

Software tools: Softmax Pro, Cell Quest Pro, Bio-statistical Software (SPSS)

References

AKIO OHTA,

Assistant Professor (New England Inflammation and Tissue Protection Institute)

Northeastern University, Boston, MA

T: 617-***-**** e: *.****@***.***

AKIKO OHTA

Research Associate (New England Inflammation and Tissue Protection Institute)

Northeastern University, Boston MA, U.S.A

Email: **.****@***.***

LYNDA ZORN

Quality Control Manager, Immunology systems

Life Technologies

Email: ******@*****.***

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