Quality Assurance Manufacturing

Anithakumari Dulapalli

Contact Phone# 650-***-****

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

Objective

Research Associate/R & D Scientist

Professional Experience Summary

- Knowledge of Current Good Manufacturing Practices (cGMP) and Food and

Drug Administration (FDA)

- Experience in Western Blotting, ELISA, HPLC, Column Chromatography,

Affymetrix Gene Chip Fluidics Station 450, UV/Vis-Spectrophotometer and PCR

- Experience in Protein Production, Purification, and Analysis, Fluorescent

Microscopy and DNA Sequencer

- Experience in Specimen Accessioning, Isolation and Propagation of

Bacterial cells, and Mammalian Cells

- Experience in manufacturing processes and equipment procedures

- Experience in Outbound Fulfillment, Video microscopic Inspection and

Visual Inspection

- Excellent skills in weighing, measuring, the raw material.

- Experience in Microsoft word, Microsoft Excel, Outlook and Microsoft

Power Point

- Experience in LIMS, File Maker Pro Database, Soft Max Pro, and Master

Control

Professional Experience:

Molecular Diagnostic Lab, (Counsyl) Redwood City, CA October 2010-

January 2011

(Clinical) Lab Assistant (Independent Contractor)

Accomplishments

- Performed Specimen receipt, Accessioned patient samples and managed

sample storage inventory

- Organized the work flow for Clinical Laboratory Scientists

- Created daily batch records for DNA Extraction, DNA Quantification, and

TaqMan/Real-time PCR by using LIMS

- Assisted with washing, staining and scanning Gene Chip Mapping 500K probe

arrays.

- Responsible for bleaching the fluidics stations and running the

Affymetrix Gene Chip Fluidics Station 450

- Performed outbound order fulfillment/ shipping DNA kits to physicians and

patients

- Performed fluidics station bleaching by using the Gene Chip Operating

Software

- Prepared buffers, staining solutions, and cleaning solutions for each

experiment

- Recorded daily temperature of refrigerators, freezers and maintained

laboratory equipment, logs and records

Zosano Pharma, Fremont, CA September 2009 - Feb

2010

Manufacturing Associate II -Temp

Accomplishments

- Performed tasks and activities in accordance with cGMP's, FDA, and ISO

guidelines

- Supported Process Engineering, System Design Engineering, and Formulation

personnel to provide product support

- Performed line clearance and inspection of in-process and final products

- Supported drug delivery systems equipment Set-Up, Operations, and

Troubleshooting in manufacturing environment

- Formed, inspected, and measured thin titanium micro projection arrays,

executed experimental, clinical, process validation operations, and

performed analytical measurement and basic data analysis

- Working to a manufacturing schedule notifying the manufacturing team

leader of any issues that may affect the on-time completion of the process.

- Preparing and completing all process documentation accurately, legibly

and in a timely manner.

- Operate packing machines to ready finished product for shipment to the

customers required standards.

Genitope Corporation, Fremont, CA May 2007- May 2008

Quality Assurance Associate

Accomplishments

- Reviewed quality assurance data to ensure consistency with company

policies and procedures; coordinated and communicated the cGMP and GDP

issues with departments involved

- Responsible for supervising contractors and maintenance personnel.

- Monitored Deviation reports, coordinated investigation of deviations, and

revised SOPs as necessary

- Reviewed LMS Facility Monitoring Alarm system Data, Production, Molecular

biology, QC, Cell Culture Reagent Records, and logbooks

- Preparing and completing all process documentation accurately, legibly

and in a timely manner.

- Generated new and revised specifications for raw materials and performed

incoming raw materials inspection

- Collaborated with QA team to do Inspection, Release, Labeling, and

Shipping of Final Product to the clinical sites

- Performed verification of transfer or destruction of in-Process material

and Drug substance to R & D group

- Recorded daily temperature of refrigerators, freezers, and chart

recorders

Genitope Corporation, Fremont, CA January 2007- May

2007

Bioprocessing/Manufacturing Associate I - (Cell Production) Temp

Accomplishments

- Preparing and completing all process documentation accurately, legibly

and in a timely manner.

- Responsible for supervising contractors and maintenance personnel.

- Worked independently and scaled up culture through to 20-L cultures from

25-cc T-flasks under GMP regulations

- Clarified cultures using tangential flow filtration & prepared custom

made media by protein-G column

- Prepared documentation on batch records and adhered to all associated

SOPs

- Reviewed the equipment files & log books

- Operated production equipment in assigned areas under the supervision of

area manager

- Recorded daily temperature of refrigerators, freezers, and Incubators

Maxygen, Redwood City, CA September 2005-

June 2006

Research Associate - (Process Development) Contract

Accomplishments

- Assisted in the creation of stable CHO-K1 lines expressing recombinant Fc-

fusion proteins

- Production of recombinant proteins from stable CHO-K1 lines in roller

bottle and Fibrastage culture systems

- Concentrated production media by tangential flow filtration

- Purification of recombinant proteins by Protein-A affinity chromatography

(purified >100 mg for six different Fc-fusion proteins)

- Measurement of protein expression levels by western blot analysis

- QC of purified proteins by SDS/PAGE and spectrophotometry and generated

and presented high-quality data

- Measurement of endotoxin levels in purified protein preparations by LAL

assays

- Assisted Molecular Biology group with plasmid preparation, colony PCR,

transformation of E. coli, phage ELISAs

- Prepared buffers, staining solutions, diluents and cleaning solutions for

each experiment

- Recorded detailed laboratory observations, procedures and results in a

laboratory notebook

FibroGen, South San Francisco, CA March 2005- August

2005

Research Assistant- (Cell Biology) Internship

Accomplishments

- Measured protein expression levels from different cells by ELISA and

Performed related protein analysis

- Maintained cell lines, Set up cell based assays & experiments, and

prepared stock solutions for small molecule drugs

- Performed drug screening in cell-based assays and evaluated results; used

Excel for data analysis

Applied Biosystems, Foster City, CA March 2004-

June 2004

Lab Technician - Internship

Accomplishments

- Responsible for DNA sample preparation, sequencing and data analysis

- Conducted analysis of DNA sequence, minipreps and plasmid DNA

purifications.

- Prepared and tested PCR and sequencing reagents; collected and analyzed

data in Microsoft Excel

- Performed troubleshooting on unsuccessful sequencing runs and maintained

laboratory inventory of supplies

Education

Master of Science in Zoology, Andhra University, India 1992

Bachelor of Science in Life Sciences, Andhra University, India 1989

Courses completed at City College, San Francisco, CA

- Stem Cell Technology October 2008- January

2009

- Introduction to Bioinformatics May 2008- June

2008

- Fluorescent Cell Technology September 2006-

November 2006

- Mammalian Cell Culture and GLP & GMP principles January 2005-

April 2005

Certifications received at Regional Occupational Program, San Mateo, CA

- Biotechnology Core and Services Certification

October 2003- June 2005

- Microsoft Office (Microsoft Word, Microsoft Excel, & Microsoft

PowerPoint) January 2003 - September 2003

References: Available upon request

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