OBJECTIVE: To offer my versatile expertise as an apt fit in a wide range of scientific/technical positions.

Assistant Scientist/Research Associate in Research & Development (R&D).

Technical Associate/Technical Writer/Scientific writing in Bio-Medical/ Bio-Tech companies.

Technologist Microbiology, Hematology, Serology/Immunology, QC/QA, Chemistry Labs.

Trainer -Impart technical skills in a patient and effective manner.

BACKGROUND:

15 years of Industrial Experience. As a cross-functional team-member of R&D interfaced with Regulatory/ QA/ Validation, Process Engg, Production/ Manufacture & Marketing.

Primary experience in Research & Development of Allografts: Human Cellular Based Tissue Products- HCTP, Biologics, Medical Devices in Regenerative /Sports Medicine.

PROFESSIONAL EXPERIENCE/ CAREER SUMMARY

I. Research Associate, R&D, MTF Edison, NJ, 2007-2016 (World's Largest Tissue Bank)

(1 yr out of job market travelling outside hometown/country on a different mission)

a) Supported Senior Scientists: i) In the role of a Study Coordinator contributed to the Design of Experiments (DOE), ii)Team Player/major contributor in developmental studies such as Feasibility Study, Biocompatibility Study, Viral Inactivation Study, Bio-Burden Reduction Study, Shelf life Study. iii) Played an integral role as a Team Member of Sports Medicine Group in the development of Implants/Allografts into new pipeline products for orthopedic applications.

b) Development of Test Methods: By end point analysis of the values obtained from results set as biochemical test parameters, for tissue subjected to various test conditions.

c) Process Optimization: Based on the criterion of preserving biochemical, assayed alongside to determine the choice of chemicals/ processing duration/ media change/ tissue: processing reagent volume ratio.

d) Technical/Scientific Writing: i) In accordance with Good Lab Practices (GLP), authored Research, Developmental Protocols/ Research, Reports/Memos/SOPs.

ii) Co-authored Work Instructions (WI)& Process Forms for Process Engg and Product Insert(PI) for Marketing. iii) Risk Analysis Report on the negligibly low toxicity level of antibiotic residuals in final products by combining data and literature /RTECS. iv) As a Power User, launched the Documents in the electronic Data Base in Master Control.

e) Implementation of Process Transfer/ Production: i) Upgrading lab equipment to commercial equipment by sourcing literature and contacting manufacturers.

ii) In line with cGMP, set up 'Staging of Time Intervals' between subsequent steps to enable personnel of subsequent work-shift to merge into the process-flow to maximize yield / productivity/personnel friendly scenario. Overseeing of personnel in all the 3 shifts.

f) Lab Coordinator/ Lab Maintenance cum Management: i) Procurement of Capital Equipment such as -80C, Lyophilizers. ii) Maintained Chemical Inventory, Proper Disposal of Chemical, Scheduled Calibration and Preventive Maintenance of Equipment.

g) Lab Safety and Chemicals: i) Trained as per OSHA standards. Maintained Material Safety Data Sheets (MSDS) and Certificates of Analysis (COAs). ii) Ensured Labeling of Chemicals in accordance with HMIS and NFPA and Lab Personnel in Proper Protective Equipment (PPE). iii) Member of the Safety Committee.

Conducted Lab Audits/generated Lab Audit Reports.

h) Hematological/Serological/Microbiological: i) Residual Testing of Calcium and Citrate in Platelet Rich Plasma (PRP) products for Dental Applications by Assays (abcam). ii) Assayed for Hemolysis. iii) Tested for Biochemical proteins/Antibodies in tissue/serum by Immunological Test Methods. iv) Microbiological Sampling of Laminar Flow Hoods /Bio-Safety Cabinets: Rodac Plating /TPC.

i) Trainer: Biochemical Assay Trainer/ Liquid Nitrogen Usage Trainer for New Hires, Supervise Interns and Co-Ops in fine-tuning academic knowledge to cater to industrial requirements and standards. Trainer for Production Techs.

GENERAL DUTIES:

Evaluation of Biochemical Integrity: Performed biochemical assays/ELISAs for the quantification of panel of Growth Factors like TGFB, FGF, VegF, Type I & II Collagen and GAG (glycosamino glycans) in Cartilage, Peri-osteum, Tendons processed under different test conditions.

Data Analysis: Created Graphs in Excel for Regression Analysis;

Statistical Analysis via tools like t-tests, Anova. Data Summary Presentation using Power Point.

Sample Preparation/Submission: Wuxi-Apptec for Sterility Testing - LAL, BF, Nelson Labs-Utah for Feasibility Study, Premier Labs, Colorado for Histology Testing of animal study samples.

Record keeping: Documentation of all experiments and research details in Lab notebook and maintaining electronic databases of tissue inventory.

Performed Lab Demos: To enable Marketing/ Surgeons with familiarization of product in terms of tissue preparation and usage of application kit prior to patient application.

Evaluation of Histology Slides from Animal Study: (H&E, Verhoeff, Trichome Staining)

To evaluate post-implant site for Infiltration of Host Cells, Chondrocytes, ECM, Elastin and Collagen.

Preparation of Standard Solutions and Buffers.

Updates in Meetings: Provide data updates/data presenatation in Project Meetings.

Cell Culture:

- Isolation of Primary Cells from Native Tissue, Mesenchymal Stem Cells (MSCs)

- Passaging P0-P3 upon Confluence by Trypsinization/Centrifugation/Media Change.

- Cell Differentiation into Chondrocytes, Osteocytes, Fibroblast (Characterization-external lab).

- Evaluation using Compound Microscope/ Cell counting by Hemocytometer

- Cryopreservation of viable cellular based Tissue in 'DMSO-CellGro Media' by cooling

to optimal parameters inside the Cryomed but not below its Tg via programmed recipes.

- Cell Inventory in Liquid Nitrogen Tanks.

- Cell Based Assays Fluorescence/Luminescence (MTS, ATP, Cell Proliferation Live Dead)

SKILLS:

Protein Purification, Electrophoresis, Western Blot, Precise Micro Pipetting

Aseptic Technique, Sterile Processing, Clean Room Experience/Gowning.

Microsoft: Word, Excel, PowerPoint

Training on OSHA (Certification by National Seminar)

Training on COMMUNICATION/LISTENING Skills (Certification by National Seminar)

ACCOMPLISHMENTS/ADDITIONAL ROLES: .

Innovation/ contraption for Sterility during freezer milling: Conceived the concept of an outer vial holder to keep also the outside of the sample vials sterile. The success of this design in terms of Sterility and Logistics coaxed MTF to get a Non Disclosure Agreement from the manufacturer.

Innovation/contraption to maintain Sterility inside 10ml jars during Lyophilization: Integral role in product launching of CAM (Cartilage Allograft Matrix)

Recommendation to Process Engineering (PE): Instrumentation of tools for the 'Cap-Base Assembly Kit' to minimize recovery time and maximize the product yield.

Contribution by Liaison: As a part of 'Process Transfer' to Production, Scaled Up the Usage of Liquid Nitrogen (LN) by interfacing with Airgas company and on site Facility Dept. to replace 200Liter LN Tanks for direct filling from a Single Tower via pipe line.

Established system: Coordinated with Promega to procure at no cost the remote signaling special freezer that enables the auto-replenishing of assay kits. (Helix System)

Safety Initiative: Installed a Venting System to get rid of the expanding N2 during freezer milling causing O2 displacement. Installed an O2 Monitor to alert when the level reaches < 20% to evacuate the room.

INTERFACING/TASKS LIAISONS/WORKSHOPS:

Patent Lawyers: Provided technical write-ups/data, graphical summary/records as required for regulatory/FDA/patent submission.

Support to Marketing: Prepared Marketing Samples for Exhibitions intended for Medical Community, provided all the paraphernalia needed for onsite demo.

Shipping/Packaging Study: Assisted QA to develop Testing Protocol to evaluate packaging at extreme storage and extreme handling conditions at Cryopak, NJ.

Quality Control: Supported QC to Perform Peel Test/Burst Test at the Instron for Testing Various Packaging Units/Sutures.

Planning: Strategizing the Ordering of Liquid Nitrogen from Airgas for R&D by estimating the consumption. Verification of Invoices and their submission to Accounts for payment release.

External Testing Lab: Deputed for Chemical Processing at Ortho Bond, NJ Technology Center.

External Research Labs/Universities: Handled various types of Human Tissue like Sciatic & Peroneal Nerves, Synovial Fluid, Tendons; shipped in specially validated optimal temperature retaining shipper boxes for research studies to Parcell Labs, Case Western, University of Illinois.

Purchase Dept/Vendors: Placed orders electronically on SAP. Set up Blanket Purchase Orders. Worked with Vendors/Sales Reps of VWR and Fisher for Best Pricing and Quotes.

Animal Study: Prepared Implants for Goat/ Equine Study.

Product Insert Preparation: Technical assistance to QE/QA to facilitate end-user with the Directions for use, Proper Usage, and Contraindications.

Workshop/Seminars: Medical Design/Packaging- MDM East Expo; Lyophilization-SP Scientific;

Wuxi Apptec-Extractable, Leachable, Risk Assessments; NJ Symposium Biomaterials Science.

EDUCATION/CERTIFICATION/CREDITS:

BS in Chemistry

University of Kerala, India

AS in Medical Technology, SUNY-NY

ASCP (American Society of Clinical Pathologists)

Post Graduate Credits in Biochemistry NJIT-NJ

EQUIPMENT RELATED EXPERIENCE

CryoMed & Liquid Nitrogen/Cryotanks, Cryostat.

Heat Sealer, pH Meter, Weigh Scales, Micropipettes,

Lyophilizer/Freeze Dryer, Freezer Mill, Tensile Testing-Instron

Peristaltic Pump, Heat Sealer, Spectrophotometer, Sonicator, Homogenizer

De-Lipidizer, Ultra Sonic Baths, Advanced Tissue Processing Tanks

Radio Frequency (RF) Equipment, Differential Scanning Calorimetry

Centrifuge, Incubators, Bio-Safety Cabinets, Micro Plate Reader.

II. Assistant Scientist, R&D LifeCell Branchburg, NJ 2002 - 2006. Allografts/Xenografts.

Dissection of Human Umbilical Cord/Chorion: Isolated the vein graft to be used in Dialysis Patients as Hematological Shunts.

Processing of vein grafts: Prepared the treatment solutions and subjected the tissue through the steps of Decellularization.

III. Lab Tech, National Starch & Chemical, Bridgewater, NJ 1998 - 2001. Technical Development.

Chemical Formulation: of various hydrophilic and hydrophobic adhesives.

Mechanical Testing: Evaluated by Peel Test on Instron to verify if the bond strength (Newtons) between adhesives and the substrates meets the specs.

REFERENCE: Upon Request

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