|
|
M.Sc. (Analytical Chemistry), Andhra University, Visakhapatnam, India
Ph.D. (Analytical Chemistry) Andhra University, Visakhapatnam, India
Simple and Sensitive methods for the determination of some drugs (Clozapine, Trimeprazine Tartarate and Pentazocine drug products)
Planning of Analytical Drug Product Developments per QBD (Analytical Method Development and Compatibility Studies), Specifications, Impurity Profiling, Analytical Method Validations [(Assay, Related Substances, Residual Solvents, Dissolutions (immediate and extended release)], Stability Support to R&D batches. Method Transfer and Technical Support to Quality Control. API & Excipient Test Verifications. Support to Quality Control for Submission Batches NDA & ANDA Submission documentation and CMC Deficiency Response Support to Regulatory. Responsibility for CMC section of the drug product in developing regulatory assessments and strategies in support of new product initiatives and product lines for NDA, ANDA, and ANADA's. preparation of CTD modules for QOS and PDR sections of the Drug Product. Leading the analytical R&D team (developing, training and mentoring). Managing CRO's for projects. Planning budget and resources for laboratory/projects including annual instrumentation maintenance and calibration contracts (creating work orders, service agreements and confidential agreements). Preparation of protocols and reports for the qualification of new instruments with establishing the laboratory SOP's. Team member in HES (Health & Safety) committee, at Bayer Health Care
CMC Deficiency Response Support to Regulatory. Responsibility for CMC section of the drug product in developing regulatory assessments and strategies in support of new product initiatives for ANDA. Preparation of CTD modules for QOS and PDR sections of the Drug Product. Development and Validation of Analytical Methods, Prepare SOP's, STP's and conduct OOT's & OOS investigations. Provide technical assistance to Quality Control and Regulatory. Supporting ongoing routine and In-process Product development formulation samples throughout their developmental to the final stages as per QBD requirements.
Development and Validation of Analytical Methods, Prepare SOP's, STP's and conduct OOT's & OOS investigations. Technical assistance to Quality Control and Regulatory. Supporting ongoing routine and In-process Product development formulation samples throughout their developmental to the final stages as per QBD requirements.
Performing Routine Quality Control testing of related Substances and Assay by HPLC, Residual Solvents testing by GC, Method Transfers of finished product, Karl Fisher, Cleaning Validations by HPLC, UV (Validation of methods and Testing equipment cleaning samples).
Development and Validation of analytical methods (assay, impurities and residual solvents etc., ) testing API and Finished Products (Tablets, Capsules, Semi solids, Injections) using Analytical Techniques (HPLC, LCMS, GC, GCMS, TLC etc), impurity profiling, preparation and review of DMF's and ANDA's.
Development and Validation of analytical methods (assay, impurities and residual solvents etc., ) for testing API and Finished Products using Analytical Techniques (HPLC, LCMS, GC, GCMS, TLC etc)
Development of analytical methods (assay, impurities and residual solvents etc., ) for the testing of API's and Intermediates using HPLC, GC, Titrimetry techniques. Preparation of SOP's, STP's and Specifications for API's and Intermediates. Analyze raw materials, API's, excipients as a part of Quality Control job and supporting cGLP, cGMP activities in the Lab.
Directly Involved in the FDA inspections of the Facility for chemistry support (together with the Head Quality Control) at Cephazone Pharma LLC and Aurolife Pharma LLC divisions and passed the inspections successfully.
e-Submitter, eCTD Regulatory tools, HPLC (waters, Agilent and Shimadzu), UPLC (waters HPLC-H class),GC (shimadzu Head Space and liquid injector, Perkin Elmer, Agilent Head Space with Liquid Injector, Schimadzu GCMS, Perkin Elmer LCMS, Distek and Varian Dissolutions, Malvern and Horiba Particle Size analyzers, UV-VIS, IR, DSC, Bulk density apparatus, Karl fisher etc.,
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
resume Strength
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy