Quality Control Medical Device

SUREKHA GANGAKHEDKAR

San Jose, CA Cell: 408-***-**** Email:acemer@r.postjobfree.com www.linkedin.com/in/surekhagangakhedkar/

SENIOR SCIENTIST TEAM MANAGER TECHNOLOGY DEVELOPMENT

DIAGNOSTIC ASSAYS PROJECT MANAGEMENT QC & MANUFACTURING

Innovative Research scientist, Technical manager and problem solver with hands-on experience in ASSAY AND

MEDICAL DEVICE DEVELOPMENT, SYSTEM INTEGRATION, BIO-ANALYTICAL METHOD

VALIDATION. Adept in the development of a variety of assays for Biomarkers, Infectious disease markers

(Antibody and antigen tests), Peptides, Hormones, Vitamins, Cancer markers, Cardiac markers, Cytokines,

Angiogenesis, and Drug screen panels. Experienced in working with complex matrices: whole blood, serum,

plasma, urine, nasal and throat swabs, FFPE tissues, xenografts and cell based assays.

Directed the growth and development of assay development team and diagnostic platform at Theranos.

Provided critical data and input towards design of hardware and software for point-of care medical device.

Fostered communications with Chemistry, Engineering and Client services groups.

Initiated and executed scientific research, complex technical processes, experimental methods and discovery

strategies incorporating contemporary approaches. Possess integrity, creativity, discipline and dedication,

thriving on continuous improvement and change.

Drafted the design and implementation of quality control and manufacturing process for diagnostic assay

reagents which became a benchmark for reagent production and verification in the company.

Excellent interpersonal communication, presentation and negotiation skills with talent for building

relationships and interacting effectively with management, collaborators, clients, vendors and staff at all

levels.

Conducted product demonstrations and training at customer sites. Acted as primary contact with clients,

participated in client meetings, data analysis, ensured communication is maintained and adhered to

reporting schedule.

Technical skills

Diagnostic assay development, Rapid tests for infectious diseases, Assay calibration and validation, Protein

expression, characterization and purification, Antibody conjugation, Antibody screening, ELISA, Assay

miniaturization, Western blots, SDS-PAGE, HPLC, Capillary electrophoresis, Immunohistochemistry,

Immunoprecipitation, Mammalian cell culture, FACS, IC50 determination, Microfluidics, HTRF assays, Magnetic

bead based assays. PCR, DNA isolation, RT-LAMP assays, RFLP analysis of PCR products, DNA labeling,

Southern blot hybridization, DNA fingerprinting by multiplex PCR, Design and execution of stability studies,

Quality control, Manufacturing process for assay reagents, Calibrator prep and verification to reference standard.

PROFESSIONAL EXPERIENCE

2005 – 2013

Theranos, Inc. Palo Alto, CA

Manager, Assay Systems (2009 –2013)

Reporting to the CEO, built and managed assay development and manufacturing teams, resulting in the

development of 100+assays. Led project design, reagent procurement and development of assays on automated

assay instrumentation, system integration, validation and transfer of assays to manufacturing, reagent QC and

multiple lot calibrations. Prepared technical summaries, process transfer documents, internal reports, patent

applications, invention disclosures and presentations

Assay targets included: Biomarkers, Infectious disease markers, Hormones, Cancer markers, Apoptosis

markers, Vitamins, Cardiac markers, Drugs of abuse, Prescription medications, Antibody tests for autoimmune

disorders, Incretin hormones.

Oversaw the development of RT-LAMP assay for Dengue virus serotypes leading to successful completion of

milestone for collaborator and the finalization of additional deals.

Developed and executed 510k validation protocols as per FDA and CLIA guidelines for various biomarkers,

rapid tests for Influenza, Dengue, Malaria, and strep A for point-of care device.

Designed assay and device quality controls for test cartridges, evaluated lyophilized and ready-to use

calibrators for cartridge lot calibrations. Reviewed calibration data and ensured lot-to-lot consistency in assay

performance.

Established protocols for preparation of assay controls and calibrators, traceability of calibrators to reference

material e.g. WHO and NIST materials, storage and use during calibrations.

Configured multiplex panels for assay cartridges that were modules for Client services team to use for

company demos and customer meetings. Prepared technical documents to present at these meetings.

Established contracts with vendors and CROs to obtain reagents and clinical samples for the various projects.

Oversaw the set up of assay development platforms in the company, like Cytometry, Metabolic Panel and RT-

LAMP assays. Involved in the early stages of conducting hands-on experiments, directing scientists and data

analysis.

Designed and planned the set-up of a BSL2 facility to ensure cost efficiency and compliance with regulations.

Team Lead (2007 – 2009)

Technical lead for a team of assay developers ranging from Senior Scientists to Research Associates.

Created a step by step process to streamline accelerated ELISA development with emphasis on clinical sample

correlation to reference methods on automated assay device.

Assays were developed for improved specificity, sensitivity and validated by demonstration of inter and intra-

assay precision, dilution linearity, stability and clinical correlation to tests at reference laboratories.

Implemented a process for the Quality control and verification of all assay reagents for Manufacturing. This

involved design of the QC tests, training of personnel, documentation, data review and set up of the approval

process. This process was considered a benchmark for QC testing and manufacturing protocol in the company.

Developed a multiplex assay for the determination of incretin hormones (GLP-1, GIP) in whole blood with

drastically shorter assay time than reference test and comparable sensitivity and specificity.

Led the successful set up and demonstration of multiplex assays for diabetes panel at customer site.

Developed an immunoassay for the Pharmacokinetic (PK) evaluation of biologic drug for Asthma management.

Assay was validated to FDA guidelines. PK and the related Pharmacodynamic (PD) assays were used as a

multiplex in phase 1 trials with whole blood matrix.

Involved in the development of PK and PD assays for another Pharmaceutical collaborator for a drug to treat

Chemotherapy-induced anemia. Validated assays were used in Phase 1 & 2 clinical trials.

Designed and conducted real-time and accelerated stability studies of assay reagents and consumables for

Point-of care (POC) device. Conducted stability assessment of assay cartridges under conditions that mimic

POC situations.

Senior Scientist (2005 –2007)

Developed immunoassays for markers involved in Inflammation, Cancer, Diabetes, Coagulation and Fertility

for whole blood, plasma and serum samples.

Evaluated a variety of polystyrene surface treatment options to maximize surface adsorption of capture

proteins.

Worked closely with Engineering and Software teams to design medical device, assay cartridges and device

protocols.

Monogram BioSciences, Lab Corp Inc., South San Francisco, CA 1999 -2005

Scientist, Oncology Group (2002 –2005)

Developed VeraTagTM assays for markers involved in RTK signaling, EGFR (Epidermal growth factor

receptor) and HER receptor family. http://www.monogrambio.com/monogram-oncology/

Created multiplex protein-complex assays for EGFR family in formalin fixed paraffin embedded (FFPE) cancer

patient tissues and xenografts.

Demonstrated correlation between activated signaling pathways and drug response in FFPE cancer patient

samples.

Developed multiplex assays to quantify total and phosphorylated proteins in the signal transduction pathway.

Optimization of antigen retrieval process of FFPE sections. Evaluated effect of buffers, pH, and retrieval time.

Evaluated and optimized the use of tubulin assay as positive cell number control.

Mammalian cell culture of HEK 293, A431, MB 468, MCF7, Jurkat, SKBR3, BT 20 and T47D. Treatment of

the cell lines with stimulants under time and dose titrations.

Senior Research Associate, Proteomics (2001 – 2002)

Cloned genes of interest in green fluorescent protein (GFP) pGERK and pIV5G vectors with N and C-terminal

His and streptavidin tags.

Use of Roche RTS system to express GFP-PDGF, GFP-RAR, GFP-RAS proteins for mobility shift assays.

Used site-directed mutagenesis to generate mutant GFP that had higher fluorescence and shorter folding time

than WT GFP.

ELISA development of signal transduction pathway members like p38, JNK, ERK, AKT, MEK, Raf, Rsk,

PI3K.

Labeled antibodies with biotin & fluorophores and purified the conjugates by FPLC.

Research Associate, Enzyme Assay Development, Microfluidics, (1999 – 2001)

Responsible for developing enzyme assays in microchips to support HTS instrument development. Targets

included cytochrome P450, phospholipase c, platelet derived growth factor - receptor binding and src kinase.

Developed and optimized conditions for electrophoretic evaluation of multiplexed kinase assays in microfluidic

arrays.

Method development for the separation of assay products on ABI 3100 genetic analyzer and data analysis.

Trained junior associates in assay development and electrophoretic analysis on microchips.

Connetics Inc., Palo Alto, CA

Summer Intern 1998

Isolated and characterized four recombinant Relaxin variants (human) by HPLC, tryptic peptide mapping, reduction

analysis and mass spectroscopy.

San Jose State University, San Jose, CA. 1997 -1999

Research Assistant

Synthesized and characterized cation-exchange stationary phases for HPLC. Silica surface was modified by

hydrosilation and evaluated by elemental analysis, CP-MAS NMR and FTIR. Gangakhedkar, Surekha,

"Synthesis and characterization of ion exchange bonded phases for HPLC" (1999). Master's Theses.

Developed HPLC methods for analysis of amino acids, nucleic acids and theophylline derivatives on the

columns.

PUBLICATIONS

Published in peer reviewed Journals

EDUCATION

M.S. in Chemistry, concentration in Biochemistry, San Jose State University.

B.S. in Microbiology, Chemistry and Botany, Osmania University, India.

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