Medical Coding Chemist

JASMINE SHAMINE RAJAYYAN

Chemist

Chemist with experience in Analytical Research and Development

SUMMARY

•Chemist with expertise in testing Transdermal, Oral Solids (Capsules and Tablets), Oral Liquids (Solutions and suspensions) and Topical Solution dosage forms (CONTROLLED and NONCONTROLLED SUBSTANCES).

•Proficient in Analytical instrumentation techniques which includes Dissolution testing, UV/Vis Spectroscopy, Particle size analyzer, Karl Fisher Titration, Next Generation impactor, Spray VIEW Measurement System.

•Proficient in Analytical instrumentation techniques which includes HPLC, UPLC, Empower Software, UV/Vis Spectroscopy, Dissolution testing.

•Well versed in calibration of instruments such as pH meter, analytical balances, Density meter, Spray VIEW Measurement System.

•Involved in CHANGE CONTROL, DEVIATIONS and laboratory INVESTIGATIONAL activities along with CAPA.

•Comprehensive knowledge of ICH guidance’s cGMP, GLP and FDA regulations

•Proficient in API, Finished Product Quality Control release and stability analysis, Validation at AR&D.

•Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format.

•Excellent communication skills & Good interpersonal skills.

•Team player, ability to work under tight timelines with poise. Ability to thrive in a global, matrix environment. Ability to manage high workload and critical issues.

•Hard working, self-motivated and Ability to multi-task with attention to detail.

•Excellent planning skills involving assigning day to day activities to team members.

•Technically train group members at developing technical capabilities and provide knowledge transfer.

WORK EXPERIENCE

Chemist 03/2022 – Present

Odin Pharmaceuticals

Somerset, NJ

•Developed optimized and validated chemical analytical methods using HPLC, UPLC, and Karl Fischer.

•Developed, optimized and validated specialized physical test methods for MDI products such spray and plume pattern characterization, aerodynamic particle size (APSD) and dose content uniformity (DUSA).

•Performed release and stability testing of clinical batches in Metered-dose Inhalers.

•Set up and operate laboratory equipment, conduct instrument and analytical method, troubleshooting with supervision.

•Prepared and maintained accurate records in lab notebooks of all testing performed.

•Followed protocols, methods, standard operation procedures.

•With supervision, investigate deviations, out-of-specification and out-of-trend results.

•Prepared standards and specifications in compliance with cGMP/GLP regulations.

•Conducted lab work in accordance with SOPs; assure compliance to Quality procedures and follow safety rules and procedures. Complied with all Corporate guidelines and policies.

•Trained APSD, Delivered Dose Uniformity, use of HPLC, karl fisher, Spray pattern and other instruments to fresh joiners.

•Responsible for performing the Analytical method validation or verification for Assay, Related substances.

•Responsible for the maintenance of the SOP’s of the laboratory equipment.

•Created and assisted with writing COA, Validation protocols, Method and Method revisions, Amendments and Deviations.

•Understanding of USP chapters and performing analytical testing for some drug related excipients.

•Well experienced in maintaining laboratory documentation electronically and handwritten.

•Responsible for entry of the sample and raw material data and logbook maintenance.

•Well documented and maintained laboratory notebooks and records.

•Prepared the mobile phases, buffers, solvent mixtures, working standards for various methods.

•Accurately documented all the information in AR&D Write-Up pages, standard and solution logbooks according to cGMP requirements.

Chemist 11/2021 – 03/2022

Novitium Pharma

East Windsor, NJ

•Responsible for performing the Analytical method validation or verification for Assay, Related substances, Blend Uniformity and Dissolution testing.

•Responsible for handling the Density Meter, Viscosity Meter, Ultra-Violet (UV) Spectrophotometer and HPLC during API, Drug product and stability Release.

•Responsible for analytical testing, analytical data review, as well as interpretation of data systematically to derive justifications for product response.

•Responsible for the maintenance of the SOP’s of the laboratory equipment at AR&D laboratory.

•Created and assisted with writing COA, Validation protocols, Method and Method revisions, Amendments and Deviations.

•Expertise in performing dissolution testing for extended drug release products.

•Understanding of USP chapters and performing analytical testing for some drug related excipients.

•Well experienced in maintaining laboratory documentation electronically and handwritten.

•Responsible for entry of the sample and raw material data and logbook maintenance.

•Well documented and maintained laboratory notebooks and records.

•Prepared the mobile phases, buffers, solvent mixtures, disso media, working standards for various methods.

•Worked with various ancillary laboratory equipment like centrifuge, water baths, stir plates, sonicators.

•Accurately documented all the information in AR&D Write-Up pages, standard and solution logbooks according to cGMP requirements.

Chemist 12/2016 – 05/2017

Novitium Pharma

East Windsor, NJ

•Responsible for performing the Analytical method validation or verification for Assay, Related substances, Blend Uniformity and Dissolution testing .

•Responsible for handling the Density Meter, Viscosity Meter, Ultra-Violet (UV) Spectrophotometer and HPLC during API, Drug product and stability Release.

•Responsible for analytical testing, analytical data review, as well as interpretation of data systematically to derive justifications for product response.

•Responsible for the maintenance of the SOP’s of the laboratory equipment at AR&D laboratory.

•Created and assisted with writing COA, Validation protocols, Method and Method revisions, Amendments and Deviations.

•Expertise in performing dissolution testing for extended drug release.

•Understanding of USP chapters and performing analytical testing for some drug related excipients.

•Well experienced in maintaining laboratory documentation electronically and handwritten.

•Responsible for entry of the sample and raw material data and logbook maintenance.

•Well documented and maintained laboratory notebooks and records.

•Prepared the mobile phases, buffers, solvent mixtures, disso media, working standards for various methods.

•Worked with various ancillary laboratory equipment like centrifuge, water baths, stir plates, sonicators.

•Accurately documented all the information in AR&D Write-Up pages, standard and solution logbooks according to cGMP requirements.

Medical Coding - Quality Analyst 05/2012 – 04/2016

Dell International Services Omega Healthcare Sysinformation Healthcare

Bangalore, India

•Quality control analyst

•Educate the associates in minimizing coding errors

•Complete knowledge on ICD-9CM, CPT and HCPCS level II.

•Maintaining the complete knowledge of Medical Terminologies.

•Ensuring the confidentiality in PHI as per the HIPAA compliance.

•Coordinating Team

EDUCATION

Master’s in biotechnology 05/2010 – 04/2012

Periyar University, Salem (Aggregate: 7.8 CGPA)

Hosur, India

Bachelor’s in biotechnology 04/2007 – 04/2010

Manomaniam Sundaranar University, Tirunelveli (Aggregate: 7.3 CGPA)

Miriagiri, India

ACCOMPLISHMENTS

•Medical coding AAPC certified.

•Best performer award received multiple times

•Star of the Month award received multiple times.

•Published paper on Anticancer activity of Marine Sponge “Sigmadocia Carnosa”.

•Research performed on Antimicrobial, Antifungal activity of Shrub “Nerium Oleander”

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