Divyank Soni

****, ********* ******, ***** *********, NJ-08902-USA,

Cell-+1-848-***-****

Email- ac4ate@r.postjobfree.com, ac4ate@r.postjobfree.com

Objective:

Seeking full-time opportunity to pursue research in analytical chemistry.

Skills:

Hands-on experience in:

- HPLC, UPLC: Waters acquity system - H/M class,

Agilent - 1100/1200, Shimadzu UFLC - 20AD.

- LC-MS/MS method development for biomarkers and analytes.

- TripleQuadruple LC-MS/MS system - ESI/APCI: Sciex - 4000 Q-trap and 6500,Waters - Xevo TQS.

- Type of separation: reverse phase, size-exclusion chromatography (SEC), HILIC.

- Software: Analyst, Mass Lynx, Chemstation, Empower.

- Estimation of analytes from p'ceutical dosage form, raw material, blood, plasma, serum, tissue and FFPE samples.

- Analytical/bioanalytical validation according to USFDA guideline and degradation study.

Additional skills/knowledge of:

- BCA assay, total protein assay, western blotting(SDS-PAGE)

- Nanodrop, qubit fluorometer, plate reader

- Uv/Visible/Fluorescence spectroscopy/FTIR

- Familiar with protein purification techniques(AKTA system)

- Different extraction techniques (SPE, LLE, PPE)

- Metabolite identification, protein binding study

- LCMS detection of protein and peptide

- Formulation and development

Professional experience:

1. DMPK Intern

Agios Pharmaceuticals, MA, USA June '17-Aug. '17(3 months)

- Assisted with early discovery DMPK bioanalysis for preclinical research for cancer and rare genetic disease drug development.

- Extracted biomarkers from blood, plasma and both frozen/ formalin fixed (FFPE) tissue samples for cancer drug discovery research projects.

- Worked on LC-MS/MS with qualification for quantitative In vivo and Invitro sample analysis.

- Trained with: Water Xevo TQS (UPLC M class, Mass Lynx, Empower),

Sciex 4000, 6500 (Analyst software).

2. Graduate Researcher

Long Island University, NY, USA Sept. '16-June '17(10 months)

- Developed UPLC-MS/MS method for 7 constitutes all together and validated according to the USFDA bioanalytical validation guideline (ESI ion source, MRM, SRM).

- Basic understanding of pharmacokinetic principle(compartment/non-compartment analysis), Metabolite identification.

- Instruments used: Sciex - 4000 Q-trap with Shimadzu (20 AD)(LC-MS/MS), Waters UPLC (H class).

3.Analytical intern (Manufacturing Sciences dept.)

Bayer Healthcare, CA, USA June '16-Aug. '16(3 months)

- Worked in the analytical department for manufacturing sciences at recombinant protein production Plant.

- Performed total protein determination by various analytical methods for downstream protein samples.

- Instruments used: RP-HPLC and HPLC-SEC (Agilent 1200 - chemstation), total protein assay, nanodrop, qubit fluorometer and plate reader.

4.Research Intern

Marck Biosciences LTD July '13-Feb. '14(8 months)

- Worked in formulation department and analytical department.

- HPLC method development, validation, and degradation study.

- Quality by design and development of new dosage form (I.V. and Ophthalmic).

- Handling of HPLC, UV, and FTIR.

- Method development strategies, validation.

5. Analytical Trainee

Molecule Laboratory Oct. '13-Nov. '14(1 month)

- Onsite training course for HPLC and dissolution technique.

- Trained in HPLC method development and troubleshooting.

- Validation as per ICH and degradation study.

6. Internship

Ipca Laboratories Ltd Nov. '10-Jan. '11(3 months)

- Worked as an intern at Ipca laboratory limited for 3 months in between 2010 to 2011.

- Became familiar with various departments and industrial environment.

- Assisted in quality control, packaging store and production department.

Education:

1. MS in Industrial Pharmacy from Long Island Uni., NY, USA.

GPA - 3.8 2015-2017

2. Masters in Quality Assurance from Gujarat Tech. Uni., India.

GPA - 3.7 2012-2014

3. Bachelor of Pharmacy from Uni. of Pune, India.

GPA - 3.5 2008-2012

Additional courses:

1. Waters e-learning course," Intact protein analysis - Instrument setup and data acquisition". Jan. '18

- Learn regarding instrument setup of Q-TOF mass spectrometer for intact protein studies, instrument tuning, mass range

for data collection, accurate mass measurements, method file creation for intact protein analysis.

2. Waters e-learning course," Peptide mapping analysis: Instrument setup and data acquisition." Jan. '18

- Learn regarding instrument setup of a Q-TOF mass spectrometer designed specifically for peptide analyses, an overview on instrument tuning, mass range for data collection, and assurance of accurate mass measurements.

3. Online training provided by waters on, "Protein analysis by LCMS tips & tricks-Web-based training". Dec. '17

4. edX online certificate course," Proteins: alignment, analysis, and structure."(Pursuing) Nov. '17-current

- Regarding protein structure and its impact on function, practice aligning protein sequences to discover differences.

Research Projects:

1. Application of microsampling for biomarker detection in PKPD study using different devices (at Agios).

2. LC-MS/MS quantitation of major grape polyphenols in mice tissue with metabolite identification (at LIU).

3. RP-HPLC method development to check deviation in protein chemistry during the upstream process (at Bayer).

4. Total protein determination by HPLC-SEC and other analytical methods for downstream samples (at Bayer).

5. Method development, validation, and degradation study for simultaneous estimation of Gatifloxacin and Dexamethasone Sodium Phosphate in the ophthalmic formulation (at GTU).

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