- Montgomery Street, San Francisco, CA 94105
- (555) 432-1000
- resumesample@example.com
- Date of Birth:
- India:
- single:
- 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,. Identification and implementation of corrective regulatory measures and partners with team members to execute wherever necessary. Responsible for leading cross-functional teams to cover critical regulatory topics related to the CMC section of the drug product. Evaluation of results of studies and other tests. Evaluates regulatory impact of product changes. Review Product labeling and batch records. Preparation of Technical files including product development reports and Quality Overall Summary . Responsible for achieving project goals, milestones and labeling from development to product life cycle. Well versed with e-submitter and eCTD documentation and submission process.
- CMC: Development and Validation of Analytical Methods for Drug Substances, Pharmaceutical Excipients and Drug Products [Injections, pastes, chewable, suspensions, pledgets, sprays, ointments, capsules, Tablets (Immediate, Extended Release and controlled release (having Bilayer and multilayer coatings), Tablet in Tablet and Tablet in Capsule & Capsules] for Related Substances, Dissolutions, Assay, Residual Solvents, cleaning Validation, USP equivalency studies and development of USP Alternative methods. Supporting analysis of Stability samples and trending Stability data for Drug Products containing single active, combination of two actives and three actives in the drug product
- involved in Quality documentation and review of OOS, OOT's, Investigations, incident reports and CAPA for laboratory related issues.
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Andhra University - Visakhapatnam,
M.Sc. (Analytical Chemistry), Andhra University, Visakhapatnam, India
Andhra University - Visakhapatnam,
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)
Five Guys – Hicksville, NY,
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
Amazon – Wayland, MA,
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.
Planet Pharma – Richmond, VA,
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.
Grifols Inc. – Pasco, WA,
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).
Dartmouth College – Hanover, NH,
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.
Aurobindo Pharma Research Centre – City, STATE,
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)
Mylan Laboratories – City, STATE,
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.,
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School Attended
- Andhra University
- Andhra University
Job Titles Held:
- Manager, Head Analytical Development & Validation
- Manager, Analytical Research & Development
- Assistant Manager
- Research Scientist
- Scientist
- Research Associate -IV
- Research Associate
Degrees
- M.Sc.
- Ph.D.
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