Analytical Chemist

Objective: To obtain a position of an Analytical Scientist in a well

reputed organization.

Profile

. Sound Academic background (GPA 4.0/4.0) along with diverse experience

in Pharmaceutical industry including Quality Control and R&D.

. Strong analytical skills in HPLC, GC, Dissolution Apparatus, Karl

Fischer, FTIR, UV/VIS spectrophotometer, pH meter, Viscometer and all

lab instruments including wet chemistry.

. Experienced with major lab soft ware including Waters Empower 2,

Totalchrom data acquisition soft wares and LIMS system.

. Well versed in cGXP compliance for FDA regulations and ICH guidelines

for drug industry and strict adherence to Standard Operating

Procedures.

. Proven Team Player with outstanding oral, written and documentation

skills.

. Sound knowledge and understanding of Laboratory Health and Safety

procedures.

Work Experience

Merck, Rahway, NJ

2012(Aug) - 2012(Dec)

Analytical Chemist (II)

. Independently performed instrumental analysis of API assay, forced

degradation study for impurities in compliance with FDA and ICH

guidelines to support clinical testing.

. Showed excellent mathematical skills and meticulous approach for data

interpretation and documentation in electronic notebook and LIMS

system.

. Performed method development using sound chromatography principles,

literature search and as a part of a team of highly skilled analytical

chemists.

Catalent Pharma, Somerset, NJ

2011(Jun) - 2012(Jan)

AR&D Scientist

. Exhibited excellent analytical techniques and skills for Dissolution

Apparatus, HPLC, UV/VIS spectrophotometer, Karl Fischer,

Disintegration and pH meter.

. Consistently performed tests of Assay, Related substance (Impurity

Profile), Dissolution and Water with accurate and pr cised results

under tight deadlines without errors.

. Successfully showed meticulous and precise approach for stage 1, 2 and

3 dissolution testing and data reporting with accurate calculations.

. Showed excellent documentation skills in compliance with GXP

compliance and SOPs requirements where detailed scientific and

mathematical explanation is required.

Johnson & Johnson, Skillman, NJ

2010(Aug) - 2011(Mar)

AR&D Scientist

. Responsibilities: Performed AR&D Method Development, Validation and

Transfer for FDA remediation projects as well as important pipeline

projects.

. Performed all the GXP data entry in the LIMS system on day to day

basis including log in sample, receiving, keeping tests update,

entering results and following LIMS sample cycle, keeping track of

specifications also.

. Carried out forced degradation study and identified

impurities/degradation products.

. Performed Method Validation (Assay, impurities) which includes

parameters such as Linearity, Accuracy by spiked recovery, Precision,

Forced Degradation, Robustness, intermediate Precision, LQL, LDL while

maintaining excellent documentation.

URL Pharma, PA

2009(Jan) - 2010(Jul)

Analytical Chemist

. Independently performed analysis of API, bulk and finished products,

scale-up samples, process validation samples and stability study

samples

. Gained valuable expertise for the analytical instruments such as pH

meter, Dissolution apparatus, HPLC, UV/VIS, Karl Fischer and FTIR.

. Performed Method Development and performed Method Validation for

Assay, Related Substances (impurities) of Drug products.

Guardian Drug Company, NJ

2005(Dec) - 2006(Dec)

Quality Control Chemist

. Physical and chemical analysis of raw material, in - process, finished

and stability products as per SOPs and FDA guidelines.

. Performed analysis using HPLC, UV/VIS, FTIR, KF, Dissolution Apparatus

and wet chemistry.

. Navigated and interpreted USP/NF general chapters and individual

monographs for most updated status of Lab SOPs and instrument

procedures.

Education

. AAPS (Academy of Applied Pharmaceutical Sciences) certificates

in HPLC, Dissolution and Analytical Lab Testing.

. Industrial Pharmaceutical Technology Certificate (12 courses)

(High Honors) Seneca College, Toronto

. Bachelor of Science (chemistry)

M.G.Science Institute, Gujarat, India

Awards

President's honor award Highest Academic Achievement. (GPA 4.0 / 4.0.)

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