Sridhar bhogavalli

• Lead the nitrosamine remediation of several on-market sterile injectable products, from risk assessment to excipient evaluation for Nitrite content.
• Lead the early phase analytical method development, pre formulation (Solubility Screen) and formulation process (particle size) for simple solutions to complex long-acting sterile injectable dosage forms (suspensions, emulsions, peptides).

PAT (Process Analytical Technology) support with inline/offline measurement of Particle size & phosphate content in the pilot scale manufacture of liposome based Covid-19 placebo, in addition to formulation support under aggressive timeline

• Key supporting role in establishment of LAR platform using a model drug (microsphere, gel and oil) through development of different analytical methods (drug load, residual solvents, particle size, moisture content, in vitro dissolution) for formulation screening
• Sameness study analytical support for peptides that include CD (Near & Far UV), Intrinsic Fluorescence and AF4
• Played a critical role in approval of complex emulsion based ANDA through development of invitro dissolution method as part of BE
• Authoring & peer review of eCTD sections as part of regulatory ANDA submissions
• Author, review of method validation protocols, reports.

• Early phase analytical method development (Assay/RS, residual solvents, Dissolution) support for niche & complex long-acting sterile injectable dosage forms like suspensions, emulsions, peptides, and liposomes
• Experienced in development of reverse phase UPLC methods for peptides with critical impurity separation and SEC to determine peptide aggregation
• Efficient in handling/providing support for high priority complex projects with short timeline, which includes method development, prevalidation and formulation support
• Formulation support for ANDA and 505(b)(2) filings with respect to Assay & Impurity analysis, filter compatibility and tubing studies, admixture studies by HPLC and head space oxygen analysis by GC
• Played a critical role in first to filing of complex ophthalmic emulsion based ANDA through development of invitro dissolution method in a very short period
• Author & review of analytical method development reports, method validation protocols, reports
• Experienced in reviewing extractable& leachable (E&L) stability data for ANDA submissions.

• Lead & supported the analytical method development (Assay/RS, residual solvents) prevalidation, validation studies for sterile injectable sustained release drug products that are developed on PLGA based microsphere-based drug delivery technology
• Supported the routine analytical testing that include in-process, finished product stability testing following the cGMP guidelines and standard operating procedures
• Author, review of method validation protocols, reports.

• Assisted with HPLC assay method development for API, drug product by performing prevalidation studies and executed the method validations
• Independently lead the development, validation of analytical method to quantitate residual solvents in API and Liposome based product using GC headspace
• Routine testing & analytical support for ANDA batches that include API, In-process and final product release testing
• Assisted with the cleaning study method development for a cytotoxic injectable drug product (based on rinse and swab recovery technique)
• Maintenance and troubleshooting of the analytical instruments like HPLC, GC & KF.

• Routine analytical testing of raw materials (API), in process and finished injectable drug products using analytical instruments like HPLC, GC following the cGMP guidelines and standard operating procedures
• Handled, managed complex analytical raw material projects that include schedule, coordinate, and prioritize based on the production schedule
• (Always submitted the regular and complex raw material projects right first time without any deviations/investigations)
• Trained new Chemists in getting acquainted with analytical instruments like HPLC, GC, KF, pH meter and UV-VIS spectroscopy
• Provided technical support to Quality Control & Quality Assurance in OOS Investigations, root cause analysis
• Peer review of analytical data and participation in the Quality improvement process.

• Worked as an instructor for Undergraduate Chemistry Students to tutor, help with the General chemistry laboratory course
• Prepared, conducted, and graded exams, quizzes for Undergraduate students.

• Media preparation for cell culture, isolation of DNA, cell transformation and review of literature on Topoisomerase II enzymes.