Shri Ravi Email & Phone Number

High Point, North Carolina, United States

High Point, North Carolina, United States

- Train laboratory colleagues, lead laboratory investigations, deviations, and larger-scope projects.- Perform routine analytical testing to support pilot plant production activities for early and late phase clinicals and commercial projects and ensured compliance of analytical data with cGMP and FDA regulatory requirements.- Author analytical methods, SOPs in compliance with quality systems, FDA/USP/ICH guidelines.- Comply and promote adherence to OSHA/EPA/ES&H guidelines, identify safety near miss to consistently enhance site safety. - Contributed to the development of non-clinical toxicology study reports for drug substances.-Played a key role in supporting and executing site audit readiness activities for both client and quality audits.- Collaborated seamlessly with cross-functional teams and global counterparts to facilitate the creation of comprehensive dossiers.

Hoschton, Georgia

- Handled Investigation reports, CAPA, root cause analysis, Out of Trend/Out of Specification data and change control documents.- Served as a functional area lead in the development of analytical dossiers.- Played a key role in addressing ANDA deficiency letters related to quality, ensuring timely and thorough responses and securing simultaneous ANDA product approvals.- Conducted and authored reports for the analytical method development and validation of ANDA solid oral dosage forms.- Served as a functional area lead in the development of analytical dossiers.- Played a key role in addressing ANDA deficiency letters related to quality, ensuring timely and thorough responses and securing simultaneous ANDA product approvals.- Facilitated effective communication with external vendors and clients to gather essential documents such as DMF, COA, BSE/TSE statements, ensuring successful product approval.

Winder, Ga

- Collaborated as a team member for FDA Pre-Approval Inspection (PAI) readiness.- Prepared responses to FDA 483 observations.- Assisted in drafting annual product reports for commercial products.- Reviewed FDA requirements and guidance documents for the implementation and maintenance of pre- and post-approval stability studies for commercial and ANDA products.- Conducted analytical testing for ANDA and commercial products- Drafted analytical methods and protocols to support Module 3 in eCTD submissions.

Athens, Georgia Area

• Comparison of different plasmid isolation techniques to determine maximal plasmid yield• Isolation and purification of plasmid containing TEV-GFP • Plasmid quantification and transformation of E.coli with plasmid containing TEV-GFP• Scale-up of protein production using bench-top bioreactor.• Protein purification using ACTA and confirm using SDS-PAGE.

Boston, Massachusetts

• Formulated and synthesized drug conjugates using supramolecular chemistry.• Synthesized and characterized single, chimeric and antibody coated nanoparticle.• Studied the effect of single, chimeric and antibody coated nanoparticle on pediatric neuroblastoma.• Maintained mammalian cell lines, isolated tumor and immune cells.• Performed T cell activation, coculture assay, drug release kinetics, toxicity testing, western blotting and flow cytometry.

Chennai Area, India

• Developed cost-effective magnetic nanobiocatalyst harboring inulinase, produced from A. niger, by various immobilization techniques such as adsorption, cross-linking and entrapment for production of high fructose corn syrup.• Characterized magnetic nanobiocatalyst based on pH, temperature optima, operational stability and re-usability.

Chennai Area, India

Cert, Biopharma Regulatory Affairs

Professional Science Master’S Degree, Biomanufacturing And Bioprocessing, 3.8/4.0

Bachelor’S Degree, Biotechnology, 8.6/10.0