Quality Control Support

201-***-**** ****.*********@*****.*** https://www.linkedin.com/in/shahrajesh938

SUMMARY

Analytical Chemist with expertise in quality control, stability studies, research and development, and manufacturing. Exceptional ability to work independently and as a team member.

Skills include:

Subject Matter Expert on NMR (Bruker Avance 400 MHz) Trained five QC analysts on methodology of NMR assays and revised SOP for NMR assay

Performed troubleshooting for instrument operations, test results, and project investigations

Hewlett Packard Laboratory Automation Computer System (HP 6890 GC with software: Chemstation Allegiant)

Waters with HPLC software: Millennium32 Chromatography Manager

Empower CADS (Chromatography Data Acquisition Software System)

Strong compliance mindset including cGxPs (cGMP, cGLP), FDA DEA and OSHA regulations and SOPs

Performed lab investigations of OOS/OOT (Out Of Specification and Out Of Trend) results in Track wise/QTS/PDOCS system

Experienced in LIMS Labware system

CAREER ACCOMPLISHMENTS

Completed Yellow belt project for NMR group (to reduce the cost of NMR sample tube)

Improved surfactants to remove haziness of solutions, which prevented precipitation and produced brighter more attractive prints

Identified missing ingredients in batch of antiperspirants and deodorants, which were then added to save the batch valued at over $50K

Analyzed used solvents by soxhelt extraction, which permitted waste solvent to be recycled 4 times

WORK HISTORY

BRISTOL MYERS SQUIBB, New Brunswick NJ (June 2017 – present)

Analytical Chemist: Analytical and Bioanalytical Development

Apply knowledge and experience with modern analytical techniques such as spectroscopic applications (FT-IR, Raman, and UV-Vis) to support identity testing for clinical and commercial production of pharmaceuticals.

Responsible for the execution of analytical methods for investigational APIs and Drug Products, as well as raw materials, process intermediates, and drug product excipients.

Involved with in-process, on demand testing of final drug product formulations during the manufacturing process.

Maintain documentation of analytical and operational data and ensure compliance with cGLP/GMPs and departmental SOPs.

Collaborated with Raw Material and Production Departments to support clinical manufacturing needs and specifications.

APRECIA PHARMACEUTICALS, East Windsor NJ (Jan 2016 – Mar 06, 2017)

Quality Control, Chemist: Supported creation of first 3-D printed drugs

Provided analytical support for testing raw materials, release and stability of 3D printed drug using HPLC System (Agilent 1260 and Waters Empowers 3, 2695, coupled with UV, PDA or RI) for levitiracetam

Performed various tests, including Assay, Content Uniformity and Blend Uniformity, and Related Compound B impurity

Measuring physical properties such as Surface tension, Viscosity, LOD, pH, Hardness, Water activity, Bulk Density, Disintegration tests for drug samples

PFIZER, Pearl River, NY (2002 – 2015)

NMR Group (2005-2015), Quality Control Associate Scientist: Provided analytical support for testing release and stability Pneumococcal polysaccharides serotypes samples by NMR

Led the NMR assay method transfer and co-validation for the 13Valent vaccine, coordinating with the Andover MA manufacturing site. Performed ad hoc and research samples for serotype testing using 400 MHz NMR for 13Valent and PREVNAR

Completed several equipments change controls; initiated and resolved investigations

Tested raw material in process using wet analysis and cGMP instruments such as HPLC, KF and UV/VIS Spectrophotometer

Provided analytical support for testing cleaning validation samples using TOC Analyzer, ATI Orion Model 135 Conductivity meter and ICP-OES (Inductively Coupled Plasma Optical Emission Spectrometer)

Validated compendial analytical methods (USP/EP/ JP/ ACS) used in raw material testing

AVENTIS PHARMA, Swiftwater, PA (1999 – 2002)

Vaccine Division, Analytical Chemist: Provided analytical support to raw material testing of early stage vaccine required for testing/ in-process formulated and final samples utilizing different techniques

Tested raw material in process and finished products using wet analysis

Used instrumentation such as HPLC, GC, FTIR, UV/VIS Spectrophotometer, KF and the Polarimeter

BRISTOL-MYERS SQUIBB PHARMACEUTICAL CO., New Brunswick, NJ (1991 – 1999)

Quality Control, Analytical Chemist

Ran studies to test the following:

Radioactive and Diagnostic pharmaceuticals products

Raw materials in process and finished products using wet analyses and instrumentation such as HPLC, GC, FTIR, UV/VIS Spectrophotometer, KF and Polarimeter

USP dissolution testing performed for tablets

Stability studies of drug samples

ADDITIONAL EXPERIENCE

FUJI HUNT SPECIALTY PRODUCTS, INC., Allendale, NJ - Senior Laboratory Technician

MARCAL PAPER MILLS, INC., Elmwood Park, NJ - Quality Control Chemist

RESISTOL HATS (A division of LEVI STRAUSS Company), Newark, NJ - Chemist

EDUCATION

Sardar Patel University, India

Department of Chemistry

BS (Bachelor of Science), Chemistry

MS (Master of Science), Petrochemicals and Polymer Chemistry

Stevens Institute of Technology, Hoboken, NJ

MS partial-completion, Chemistry

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