PARESH BHATT
Lodi, NJ-07644
Phone: 973-***-****
E-mail: k36g5d@r.postjobfree.com
OBJECTIVE: Seeking Position of
Back ground: Pharmaceuticals / Analytical R&D, Product development, Method
Validation, HPLC, Q.C., Process validation, Calibration,
Diagnostics (Sales and Marketing), Urinalysis, Biochemistry, Point of
Care testing
Education: B.S. (Chemistry) From: M.S.University of Baroda. INDIA.
Residence: N.J.
Authorized to Work in U.S.A.: US Citizen
Birth Date: Feb.’27
Relocation: Ready to Relocate
SUMMARY:
Six years’ experience as Analytical Chemist in Analytical Research & Q.C. Lab of
Pharmaceutical Companies & Twenty years experience of sales & Marketing.
• Hands on experience of HPLC (Waters, Agilent, Shimadsu) UV-VIS, IR Spectrophotometer, and Dissolution Apparatus with auto sampler, KF Apparatus, etc.
• Hands on experience of HPLC Empower soft ware.
• Analysis of Solid Oral Pharmaceutical Dosage, Drug Substances and in-active substances related to ANDA submission.
• Analysis of Cleaning Verification Samples of Process Equipment.
• Method Validation of Assay and Extended Release Method for ANDA submission.(Accuracy,Precesison,Specificity,Linearity,LOD,LOQ, Ruggedness, Robustness, Stability, Forced degradation)
• Perform assigned samples using established test procedures.
• Independently plan and make adequate inventory of test reagents and solutions.
• Independently plan and execute testing to meet established time lines
• Perform and document work clearly & record the data as per specified procedure.
• Comply with all regulatory requirements (Safety, housekeeping laboratory chemicals waste, cGMP, cGLP, documentation)
• Handling of Controlled Drug Substances.
• Microsoft software (Word and EXCEL)
• LIMS work sheet preparation and P.Q. of work sheets of LIMS
• Knowledge of FDA, SOP, CGMP, GMP, cGLP, OSHA.
• Worked under FDA-21 CFR Part-820 and CAPA Environment
• Aptitude to learn new scientific technologies quickly.
PROFESSIONAL EXPERIENCE:
Chemist I, Q.C. LAB. December 2010 - December 2011
Aurolife Pharma LLC, NJ, USA
Job responsibilities and accomplishments:
• Finished products Analysis, Process validation
• Dissolution, Blend assay, Blend uniformity, Assay, Content uniformity, Cleaning validation, Water by KF testing, and preparation of Certificate of analysis.
Associate Scientist, Analytical R&D March 2005 to November 2010
Amneal Pharmaceuticals, NJ, USA
Job responsibilities and accomplishments:
• Characterization of Product development, Stability Samples of Extended Release Solid Oral Dosage.
• Execution Method Validation as per Protocol.
• Method Validation and Analysis of Cleaning Verification Samples of process equipment.
• Calibration of HPLC, UV-VIS Spectrophotometer, FT-IR Spectrophotometer, Dissolution apparatus, Analytical Balance and pH meter. And minor trouble shooting.
• Validation of Extended Release and Assay Method for extended release solid oral dosage formulation for Submission to ANDA.
• Raw material testing (Wet chemistry,ID,Heavy metals,Lod,Assay,tap density,G.C Sample prep,LOI)
• Q.C. LAB
• Analysis of finished products, Stability samples, Cleaning validation samples and Calibration of UV Spectrophotometers, pH meters, Balances and Dissolution apparatus.
• Organizing skills for laboratory chemicals, HPLC columns, Glass Ware and their inventory records on monthly basis
• Efficient completion of projects Q. C. Lab for Assay, C.U., Related compounds, Dissolution, Blend Uniformity of finished and stability samples, Cleaning verification.
• Perform assigned sampling products using various wet chemicals, physical and instrumental techniques as per USP monograph/ in-house / Compendia monographs.
• Excellent communication and administration skill.
Account Manager – Sales & Marketing February 2004 to February 2005
One Source Pharmacy N.Y. N. Y. USA
Bayer Health Care (Diagnostics)
Bayer Diagnostics India Ltd.
589, Sayajipura,
Ajwa road
Baroda. (INDIA)
Area Manager-Diagnostics January 1983 to April 2003
Job responsibilities and accomplishments:
Bayer Diagnostics, Baroda, India
• Sales and marketing for following products:
o Urine chemistry products (Urine test strips, and Urine Chemistry instruments)
o Diabetes testing strips and instruments ( Blood-glucose testing meters)
o Biochemistry testing instruments (CH-100, RA-50, RA-100, RA-1000, and Opera)
o Reagent Kits for all above mentioned instruments
o Blood Cell counters
• Demonstration and training to the customers for above mentioned products.
• Field training to the new-recruits.
• Successful track record to achieve target- product wise, unit wise and value wise.
• Excellent rapport with customers and distributors of the assigned areas.
• Excellent interpersonal communication skills.
• Excellent rapport with head office staff and colleagues.
• Excellent rapport with leading Pathologists and Medical Directors of the leading private, trust and industrial hospitals.