Prakash Sojitra
Experienced Quality Control, Analytical R&D, CMC Professional
- Role
- Senior Scientist at Genus Lifesciences Inc
- Location
- Allentown, PA, US
- LinkedIn followers
- 500 followers
About Prakash Sojitra
Advance knowledge and skills in the application of the principles and techniques of analytical methods.• Demonstrated leadership in managing multiple analytical projects and preparing technical documents for ANDA submissions.• Proficient in operation of HPLC/UPLC, GC, GC-HS, UV/Vis, FTIR, Karl Fischer/Auto Titrator, Malvern Particle size analyzer• Expert in Dissolution method development using multimedia dissolution for Biostudy.• Experience in working on method validation, method verification, method transfer as per ICH, FDA and USP guidelines.• Experience in finalization of specifications for different products using FDA and ICH guidelines after completion of stability studies.• Excellent in writing-review of protocol, report, analytical procedure, SOP, material specification, finished product specification, In-process specification, stability protocol, Freeze thaw study protocol, and In-use study protocol. • Experienced working on FDA’s deficiency such as IRL, CRL and DRL. • Expert in Water’s Empower software in creating reporting methods and custom feilds• Excellent oral and written communication skills to communicate with the team, peers, management and contract laboratories for internal and outsourced projects.• Experience in working with software such as LIMS, Master control and MS office (Word, Excel, and PowerPoint).
Experience
Senior Scientist
Mar 2014 — Present · Allentown, PA, US
Education
Hemchandracharya North Gujarat University
Bachelor of Pharmacy - BPharm, Pharmacy
Hemchandracharya North Gujarat University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Science
2003 — 2007
Governors State University
Master of Science (MS), Analytical Chemistry
2009 — 2010
Skills
- Microsoft Word
- Glp
- Uv-Vis
- Dissolution Testing
- Protein Chemistry
- Cgmp
- Analytical Methods Development
- Wet Chemistry
- Analytical Method Validation
- Residual Solvent Testing
- Microsoft Excel
- Dissolution
- Bio-Analytical Chemistry
- Gas Chromatography
- Cleaning Validation
- Ftir
- Chromatography
- Stability Testing
- Chemdraw
- Graphpad Prism
- Hplc
- Validation
- Spartan
- Organic Chemistry
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