Assistant Project

B humi Dave

Edison, NJ *****● ***- ***-****

*****.****@*****.*** ●www.linkedin.com/in/bhumiidave

SUM MARY

• Contribute effectively in development and validation of bio-analytical methods using expertise in immunoassay

E LISA and ECL techniques in monoclonal and bi-specific antibodies.

• Transferrable skills for roles of Executive Assistant, Event management, Project Management Associate roles

i n pharmaceutical as well as non-pharmaceutical industry given a chance.

CORE COMPE TE NC I ES

PROJECT MANAGEMENT

• Can manage 2-3 projects simultaneously through developing methods, validation, sample analysis, report

w riting, transferring methods to CROs and providing technical support, and report writing.

• Meticulous in report writing and publishing of Pre-clinical, Clinical, and Validation Reports with use of RAPID

GD-Template (Report Writing Software), JMP 8 and WATSON-L I MS

• Proficient understanding of GCP and Regulatory Requirements along with Sample management

& Chain of Custody for Projects.

• Ability to assure adequate and appropriate dissemination of information

• Project Study archiving for GLP,Non-GLP and Clinical study using Watson-L I MS, SOFTmax, Sciex, Global GD

template

• Accomplishment - completion of approximate 10 – 15 projects successfully throughout the year.

TEC H N ICAL/SC I EN T I F I C WR I T I NG:

• Efficient in w r i ting method & validation report, standard operating procedures (SOP) for

i nstrument performance-Qualification under regulatory and safety guidelines

• Written and edited project reports of bio analytical method development, validation and sample analysis.

• Proficient in SOP writing of safety and/or performance/qualification of instrument under safety and quality

control guidelines.

• Responsible to write, format and/or review development reports, validation protocols, validation reports and

analytical methods under GLP, Pre-Clinical or Clinical guideline.

• Coordinated preparation and t imely submission of high quality documents when required

DRUG DEVELOPMENT & REGULATORY AFFAIRS

• Performed immunoassay method development and validation in different matrices for pre-clinical and clinical

sample analysis.

• Performed instrument qualification, maintenance, and documentation

• Contributed to research work to establish immune complex assays in the laboratory and presentation of

research findings in poster symposia

• Learned and developed tissue homogenization method for immunoassay analysis

• Fully t rained in regulatory requirements and SOPs governing bio-analytical work

• Achieved GLP sample analysis proficiency with no findings from QA during GLP audits

CLINICAL

• Performed method validation, sample analysis and report writing for clinical studies.

• Set up Lab following GLP, GCP protocols and assisted supervisor on clinical projects

• Performed sample analysis for clinical, preclinical and discovery studies

• Performed sample analysis for clinical samples under sterile and aseptic cGCP environment

• Recorded and analyze data and statistical calculations

• Compiled and verified data tables, authored and published bio-analytical reports for Clinical studies, Pre-

clinical, and validations

• Brought clinical knowledge and t ransferrable skills to assist with Clinical Trials

COORDINATION & ADMINISTRATION

• Coordinated with Clinical and Sample Operations to manage sample arrivals, departures, t racking.

• Coordinated with headquarters to arrange for ample supplies of reagents, plates and team for group for

required sample analysis.

• Administered shipments and method t ransfer with CRO and t roubleshoot issues.

• Trained Lab Tech in techniques and methods for analysis.

• Maintained clear communications with international publishing company and manage author signing.

• Maintained laboratory notebook for method development, assay validation, and GLP sample analysis

TRAINING & TECHNIQUES

• Immunoassays development, validation and sample analysis for PK,PD, and immunogenicity measurements

u nder GLP Compliance and OSHA Lab Standard

• Tissue Homogenization and Whole Tissue Bio-analytical Sample Analysis

• Experience working with monoclonal antibody therapeutics, Bispecific antibodies, therapeutic vaccines and

peptide drugs using Ligand Binding Assays techniques in various matrices

• Efficient in team work, t rouble shooting, and continuous communication among colleague as well as manager

• Operation, Performance Verification and Maintenance of MSD Imager 2400 Reader, Thermomax Microplate

Reader as well as Electronic Pipette Operation and Maintenance

• Efficient in documentation in laboratory notebooks and Bio analytical Electronic Notebook (BA-ELN)

• Trained on use of Micro Plate washer and Thermo Max Reader, Florescence Reader, MSD Sector 2400 plate

reader, Milli-Q Academic Water Purification System, Cell Culture Techniques

EXPER I E NCE

HO F F MAN N-LA ROC HE I NC - Bioanalytics-Non Clinical Safety, N utley, NJ

Senior Associate - La rge Molecule Bioanalytics 10/2012 – 11/2013

Associate I (formerly Scientist-Title Change due to Globalization) 02/2011 – 10/2012

Research Assistant 09/2009 – 02/2011

• Successfully progressed from a Research Assistant role to a Senior Associate level in a short

span of 3 years.

• Managed analytical aspects of several projects simultaneously from development to report writing

• Responsible for sample management – Sample Handling (Receipt, Storage & Disposal)as per GLP

requirements, maintain sample tracking paperwork.

• Immunoassays and cell-based assay development, validation and sample analysis for PK and

• immunogenicity measurements in GLP regulated environment using ELISA & ECL

• Assay support for rapid turnaround discovery programs, preclinical GLP studies in a regulated Environment

and clinical studies.

• Recorded bio-analytical work in notebooks as per SOP and GLP requirements.

TAYLOR TEC H NO LOG I ES - Method Development-I mmunochemistry, P rinceton, NJ

Analytical Chemist - B io-analytical & Cell Biology Research 02/2009 – 07/2009

COLGATE PALMOL I VE - CONSU MER PROD UCTS, EARLY RESEARCH, P iscataway, NJ

Research Assistant & Lab Technician - Biochemical and Clinical Research 05/2008 – 12/2008

I M C LO NE SYSTE MS I NC. - P HAR MACEUT ICAL, Branchburg, NJ

Operator I I & Production Assistant -Cancer Drug/Biochemical 11/2007 – 03/2008

NAT IO NAL STARCH & CHE M ICAL, Bridgewater, NJ

Lab Technician - Food Starch Quality Control 08/2007 – 11/2007

RUTGERS NEWARK U N I V E RS I TY, Newark, NJ

Lab & Student Assistant - Biology Lab 08/2006 – 05/2007

E D UCAT IO N

• Business Analyst Certificate – AveTech Institute, Piscataway, NJ ( In Progress)

• SAS Clinical T r ial software Certificate – AveTech Institute, Piscataway, NJ ( In Progress)

• M ini-MBA Certificate on Pha rmaceutical I nnovation – Rutgers University, Newark, NJ, May, 2013

• Bachelors of Arts, Biology Rutgers University, Newark, NJ, 2007

• Associate of Arts, Liberal Arts M t. San Jacinto College, San Jacinto, CA, 2003

CO MP U TER SK I L LS

• Windows and Macintosh Systems

• Laboratory Information Management Systems (LIMS) (WATSON)

• Bioanalytics-Electronic Notebook (BA-ELN) for lab experiment record keeping

• RAPID Global Dossiers Template and Report Writing Software (RAPID)and DOCUMENTUM MS Project,

A riba ScieQuest Procurement Software

• MS Office, Adobe Photoshop, Acrobat Reader, Windows O/S, Lotus Notes, Skill Pad, SOFTmax Pro, MSD Data

Reader

P UBL ICAT IO N & POSTER

• Authored ‘Detection of Drug ADA Complexes – Overcoming Drug Interference for ADA Detection’ Poster at

Roche-Nutley Poster Symposia, Roche-Nutley, NJ, 2011

• ‘Immune complex assay/detection to support pharmacokinetic evaluation of an anti-asthmatic monoclonal

antibody following IV and SC administration in Cynomolgus monkeys’, National Biotech Conference – AAPS,

2012

AWARD

• Recognition Award for establishment of new methodology and its successful implementation for project

support, Roche, 2011.

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