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Quality Control Manager

Location:
South Brunswick Township, NJ
Posted:
June 20, 2014

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Resume:

Bhavana S. Arya

Mobile: 732-***-****; E-mail: acenc4@r.postjobfree.com

Pharmaceutical professional (MS Biotech, MBA) with strong research /

development background and 10+ years of industry experience at Bristol-

Myers Squibb (BMS), Elan Pharmaceuticals and VaxInnate Corporation.

Skilled in compliance systems, document control and analytical testing

(cGLP/cGMP).

EXPERIENCE

HealthEC, Piscataway NJ

2012 / 2014

Training / Analyst

. Performed loading, validation and special edits on health care data in

Docuwise

VaxInnate Corporation, Cranbury NJ

2010 - 2011

Research Associate III, Quality Control

. Coordinated document control and revision of analytical procedures for

technical transfer to subcontractors. Performed IQ, OQ and PQ on certain

laboratory equipment

. Worked with external vendors and CMO's to ensure compliance and tracked

analytical testing using material change of custody

. Worked in a cGLP/cGMP environment using APRs, also performed in-process

testing and presented data in departmental meetings

. Involved with batch record completion and release of buffer samples to QA

custody

. Trained on Out-of-specification (OOS), Non-conformance (NC), Corrective

Action Preventive Action (CAPA), Deviations and Amendments SOPs

. Performed assays including - ELISA, BCA (colorimetric assay), LAL

endotoxin, SDS-PAGE and cell culture technique / TLR-5 assay.

Knowledgeable in Waters Empower system

Jan 2004 - Oc

Bristol Myers Squibb 2004 - 2009

Associate Training Manager, PPM Group, Plainsboro, NJ

Developed and delivered training presentation and on-line demonstration of BMS compliance enabling tool in

seminar and online formats.

Coordinated and effectively managed a cross functional team to develop the departmental Standard

Operating Procedures (SOPs) to help individuals comply with BMS Policies

Expertise in documenting business process guidelines, gathering, documenting user requirements and workflows

Interfaced with external vendors and internal resources to develop communication materials, which

enhanced learning. Coordinated website template creation, e-submissions and approvals with the Legal and

Compliance team

Negotiated and reduced expenses by 20% for the printing of job aids and other material

Research Scientist, Chemical Enzymology, Pennington, NJ

Developed and conducted assays to determine efficacy of novel BMS compounds

. Analyzed enzyme inhibition data from cyno experiments, provided critical

input to DWG for IND filing

. Performed routine gel filtration, HPLC and western blot for

characterization and purification of enzymes

. Knowledgeable in Waters and Shimadzu systems with a background in Empower

software. Experience in using laboratory automation applications and

laboratory notebook management systems

. Developed a protocol to test reversibility of potent enzyme inhibitors

. Presented results at departmental meetings, DWG meetings and poster at

16th Annual Scientific Symposium, PRI, BMS

. Received the BMS PRI star award for dedicated work as departmental safety

representative

Associate Research Scientist, Chemical Enzymology, Pennington, NJ

. Developed ex-vivo assay to assess inhibition of enzyme in tissues samples

. Performed detailed studies evaluating mode of inhibition (MOI) of BMS

inhibitors. Efficiently used Graphpad Prism, Kaleidagraph and Grafit

. Trained contract employees and new hires on safety procedures and routine

laboratory equipment

Bhavana S. Arya 732-***-****)

Page 2

Contract Scientist, Bioanalytical Sciences Pennington, NJ

. Conducted in-process testing for BMS biologicals using ELISA, UV

spectroscopy and protein purification methods i.e. SEC HPLC (Waters and

Shimadzu)

. Implemented and validated Picogreen Method for the quantitation of ds DNA

and used molecular biology techniques for DNA preparation

. Authored/co-authored internal technical documents, analytical methods,

reports contributed data towards BLA filing Trained on PD-LIMS and worked

in a cGLP / cGMP environment

Elan Pharmaceuticals, Princeton, NJ 1998 - 2003

Senior Research Associate, Biological Evaluations/Pre

clinical development

Developed novel operating procedures for cytotoxicity assays and in-vitro

combination studies. Led project management initiative regarding OSHA and

document control for QA applications. Delivered research seminars to lab

personnel.

Coordinated implementation of high throughput screening technology for drug

discovery, developed associated software-based techniques

Researched, proposed and analyzed the oral delivery aspects of liposomal

drugs using CaCO2 cell-based advanced screening technologies

Mentored and trained Temporary employees and new hires on cell culture

techniques, specific HTS software and Biomeck 2000 machine handling

TECHNICAL SKILLS

MS Word, Excel, PowerPoint, Graphpad Prism, Kaleidograph, Visio, Adobe

Photoshop and Documentum (Web publisher)

EDUCATION

MBA, Rutgers Business School, New Brunswick, NJ May 2007

. Developed marketing/brand extension strategy for Chapstick to improve

customer reach & satisfaction

. Researched application of RFID technologies at Wal-Mart to enhance

logistics support

. Compared investment merits of Intel vs. Texas Instruments

. Proficient in using Markstrat (simulation software) for

marketing strategy analysis

M.S. Biotechnology, MS University, Baroda, India May 1995

. Improved the yield of L-aspartic acid using aspartase from Escherichia

coli by mutagenesis, and selected resulting aspartic acid, fumaric acid

non-utilizing mutants, and aspartate family auxotrophs

. Developed polyethylene beads-based whole cell immobilization technique

for the transformation of ammonium fumarate to aspartic acid

PATENTS, PUBLICATIONS, AWARDS and ACTIVITIES

Bhavana Sahni-Arya et al, Cofactor specific modulation of 11?HSD-1

inhibitor potency, Biochimica Biophysica Acta 1774 (200*-****-****

Represented Chemical Enzymology Department as the safety representative for

EHS (Environmental Health and Safety) Committee at Hopewell BMS

Successfully completed (with merit) the Compliance Course of the

Occupational and Safety Health Administration (OSHA), Philadelphia, PA, Jan

2003. Designated Chemical Hygiene Officer subsequently, for Elan's

Princeton facility

Represented Elan at the ADME-Tox workshop organized by In Vitro

Technologies in Baltimore, MD, March 2002

H.Y. Tang, S. Ali, Bhavana S. Arya, A.S. Janoff, and E. Mayhew, "A novel

ceramide derivative, TLC-144, induces apoptosis in human tumor cells

through the activation of caspase 8/FLICE," submitted as US Patent

Application and Presented at the annual meeting of American Association of

Cancer Research, San Francisco, CA, Apr 2000

Bhavana Arya, "Mechanism of action of ELL-12 (Insight into involvement of

caspases)," Research seminar at The Elan Corporation, Jan 2002

Bhavana Arya, "Caspases and Apoptosis," Research seminar at The Liposome

Company, Jul 1999

Monthly scholarship (1993-95) from the Department of Biotechnology,

Government of India

Ranked in the top 5% in BS Microbiology (1990-93), University of Delhi



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