Purnima Gupta Email & Phone Number

Tampa, Florida, United States

• Efficiently process incoming test samples, data entry, review, and approval for the stability database.• Coordinate creation of stability studies and batch records, ensuring compliance with regulatory standards.• Analyze drug product stability data using statistical methods to identify trends and establish control limits.• Compile comprehensive stability reports and suggest procedural improvements for cGMP compliance.

Athens, Georgia, United States

Conducted the functional characterization of carbohydrate-active enzymes, polysaccharide structure, and protein-carbohydrate interactions using mass and NMR spectroscopy techniques

Miami, Florida

• Led 3+ magnetic nanotechnology projects for brain delivery of anti-HIV drugs and anti-addictiontherapeutics for neuroAIDS.• Wrote and conducted experiments to acquire $2 Million NIH (R01) collaborative grants.• Documented annual reports and reviewed manuscript for prestigious journals.• Excellent documentation skills in analyzing and interpreting data. Mentored 5 graduate students.• Presented scientific data at the Society of Neuroimmune Pharmacology, and NIDA Genetics conferences.

Mumbai Area, India

• Provided strategic consultancy, and communications support to healthcare clients.• Executed outreach programs to promote pharmaceutical products in diverse healthcare sectors, targetingprofessionals, patients, and support networks.

India

• Developed liposomal formulations of Levofloxacin and Serratiopeptidase for targeted delivery.• Optimized pulmonary deposition and co-spray drying techniques to enhance drug delivery.• Conducted in vitro microbiological studies to assess the anti-biofilm and antimicrobial activity.

Mumbai Area, India

• Drug safety specialist at Roche, responsible for managing adverse event information.• Proficient in utilizing software tools such as ArisG and ADVENT for adverse event tracking.• Efficiently create and manage case files, initiating drug safety reports in tracking tools and databases.• Thoroughly process and assess non-expedite cases, ensuring completeness and accuracy.• Skillfully employ medical and drug dictionaries to code medical history, medications, and adverse event terms.• Expertise in crafting comprehensive case narratives summarizing essential case details.• Proactively raise queries to Safety Responsible Personnel for missing information, ensuring data integrity.• Software and Database Proficiency: ArisG and ADVENT.• Utilize MedDRA Version 14.1 medical dictionary for accurate coding.• Competent in document transfer systems: SFT (Secure File Transfer) & Valicert.

Mumbai, Maharashtra, India

• Conducted comprehensive stability analysis on tablets, injections, and capsules, encompassing assay and related impurity assessments.• Proficiently utilized Karl Fischer's method to determine water content, ensuring product quality.• Thoroughly examined uniformity of weight and content, dissolution testing, and various other pharmacopoeial tests.• Successfully executed compatibility studies, actively contributing to method development and validation processes.• Facilitated seamless tech transfer of developed methods onto commercial production scale.• Performed in-depth stability trend analysis, identifying potential behavioral patterns across different stability time points.• Possess a strong understanding of Pharmacopoeia standards, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).

Mumbai, Maharashtra, India

• Conducted pre-formulation studies including solubility and physicochemical characterization of new APIs.• Skilled in method development, validation, technology transfer, and stability testing.• Formulated and developed sustained-release formulations, tablets, capsules, liquid orals, and topical gels.• Supported product development and compatibility studies for oral dosage forms with analytical expertise.• Performed bioavailability enhancement, dissolution studies, tablet hardness, and friability studies.• Expert in granulation, micronization, encapsulation, tableting, and tablet coating.• Designed protocols as per ICH guidelines, and prepared scientific reports, and MMD as per domestic &export requirements.

Ph.D. (Tech), Pharmaceutics

Dissertation Title: Particulate systems for Improved Pulmonary Delivery

Master’S Degree, Pharmacology

Dissertation Title: Pharmacological studies on Chronic Inflammatory disorder of the joint

Bachelor’S Degree, Pharmacy, First Class With Distinction