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Customer Service Regulatory Affairs

Location:
Silver Spring, MD
Posted:
August 14, 2023

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Resume:

PRIYANKA SRINIVASAN

***** ******** *****, ****** ******, Maryland 20901 732-***-****

adyxuc@r.postjobfree.com adyxuc@r.postjobfree.com Summary

I am an enthusiastic, passionate researcher in the field of Pharmaceutical sciences with planning and organizational skills that balance work in a timely and professional manner with a research experience and expertise in pre-formulation and formulation development by hot melt extrusion (HME) technology. Experience in formulating solid oral dosage forms such as granules, tablets, pellets by HME. Background includes performing research in the areas of co-crystals, taste masking, twin screw melt granulation, HME coupled CO2 research by applying simulation/modeling in HME. A confident and a dedicated team player with a positive attitude person inclined towards reading literature for enhanced critical thinking. Education

• Doctor of Philosophy in Pharmaceutical December 2022 Sciences- Pharmaceutics The University of Mississippi, University, MS

• Master of Science in Pharmaceutical May 2019

Sciences- Pharmaceutics The University of Mississippi, University, MS

• Bachelor of Technology in May 2016

Pharmaceutical Technology AC Tech, Anna University, Tamil Nadu, India Skills

Statistical Analysis- SPSS ~ MS Office Suite ~ Accelerated learning ~ Effective Project management ~ Writing proficiency in preparing technical reports and research articles. Strong documentation and effective time management skills. Efficient at SciNote

(ELN), Accessing chemstation, empower 3 and trios software’s for data processing and interpretation. Language skills: English

(Advanced), French (Intermediate), Tamil (mother tongue) Industry Experience

ORISE fellow-Office of Pharmaceutical Quality (OPQ), FDA January 30/2023-Present

• Working on a research project focusing on the manufacturing of polymeric devices such as implants and intravaginal rings to support the product specific guidance’s for generic drug development

• Developed characterization tools for evaluating the quality and performance of the drug product

• Hands on learning with different particle size imaging instruments such as morphologically directed raman spectroscopy (MDRS) and flowcam; morphological analysis by scanning electron microscopy (SEM), optical microscopy

• Performed in vitro dissolution studies for intravaginal discs/rings at accelerated conditions Intern Oral Formulation - Humanwell Pharmaceutical US, Inc-Ballwin, MO May 2021-August 2021

• Worked as a project intern for nasal delivery

• Performed pre-formulation studies such as screening of different surfactants and co-solvents (excipient compatibility) for the solubility enhancementof a poorly soluble drug by HPLC analysis

• Designed a prototype nasal spray formulation and monitored for stability assessment at ambient and accelerated conditions TTK Healthcare Ltd - Chennai, Tamil Nadu, India August 2016-July 2017

• Assisted the research scholars with different formulations (Pharmaceutical dosage forms) and was part of the literature review team where I examined the prior research studies on oral formulations

• Acquired experience in oral solids, oral liquids, topical preparations, immediate release and modified release tablets and polyherbal formulations

• Led the Diclofenac solution project for topical use, Doxylamine Succinate in combination with Pyridoxal 5-Phosphate and Folic acid for morning sickness during pregnancy and various nutritive supplements for children

• Gained hands on experience with several tableting techniques like granulation, particle coating, tablet coating, capsule filling machine and compression of tablets

• Worked in the manufacturing sector of sterile and non sterile oral manufacturing, packaging and cleaning process

Intern Pasteur Institute of India - Coonoor, Tamil Nadu, India April 2015-May 2015

• Acquired knowledge in production procedure and testing of DPT group of vaccines and Anti Rabies vaccine Intern Central Leather Research Institute - Chennai, Tamil Nadu, India July 2014-August 2014

• Trained in determination of molecular weight by SDS-PAGE, DNA extraction and use of collagen for biomedical application Intern Cancer Institute - Chennai, Tamil Nadu, India May 2014- June 2014

• Received training in staining and processing of tissue specimens and the usage and working of different microscopes Research/Academic Experience

Graduate Teaching Assistant - The University of Mississippi-University, MS August 2021-December 2021

• Instructed a group of 100 students for PHCY 421 Pharmaceutics and Calculations course offered by the school of pharmacy department for the Pharm D students with topics covered includes the theoretical concepts and practical experiments for Hydroalcoholic solutions, Isotonic electrolyte solutions, Buffer solutions and Degradation kinetics

• Assisted the course instructor in the evaluation of course assignments and graded the exams. (Blackboard) Graduate Teaching Assistant-The University of Mississippi-University, MS August 2022-December 2022

• Instructed a group of students for Phar 433 Pharmaceutical Industry course offered by the school of pharmacy department for the Pharm D students with topics covered GMP – Guidance, Regulatory Affairs, Quality systems, Quality assurance, Pharmaceutical development, Manufacture tablets and capsules

• Assisted the course instructor in the evaluation of course assignments and grading the exams.

• Course instructor for Phcy 400 Becoming a Pharmacist and guided the students in pharmacy workshops Research Assistant -The University of Mississippi-Oxford, MS (Advisor-Dr. Michael A. Repka) August 2018-December 2022

• Worked in the area of co-crystals, taste masking via Hot Melt Extrusion Technology (HME)

• Studied different aspects of product performance in line with process parameters of HME i.e formulation and equipment interactions and assessed the formulations under various stability conditions including ambient and accelerated (40 C 2

C/75% RH 5% RH) as per the ICH guidelines

• Performed laboratory equipment set-up and prepared experimental procedure

• Prepared and maintained purchase orders for raw materials and lab supplies inventory reports Research Projects

PhD project – The University of Mississippi, Oxford, MS August 2019-December2022

• Investigation of taste masking efficiency of caffeine citrate by lipids utilizing hot melt extrusion technology

Designed a granule formulation with different lipids by HME technique for assessing the taste masking efficiency of bitter tasting API and characterized the potential of lipids as taste masking agent by in vitro dissolution studies at pH-6.8

• Development of a lipid based extended release quetiapine fumarate tablets via twin screw granulation: Effect of formulation and processing variables on drug release characteristics

Developed an extended release tablet for highly soluble API by incorporating different polymer-lipid combination by the HME technique and assessed the drug release characteristics by in vitro dissolution studies

• Numerical simulation of five different screw configurations used during the preparation of hot-melt extruded kollidon and soluplus based amorphous solid dispersions containing indomethacin

Developed a pellet dosage forms for the preparation of amorphous solid dispersions for poorly soluble API by using hydrophilic polymers and performed in vitro dissolution studies for solubility, bioavailability and dissolution enhancement

Master’s project - The University of Mississippi, Oxford, MS May 2018-May 2019

• Evaluated the impact of polymeric carriers on the processability of Theophylline Nicotinamide pharmaceutical co- crystals utilizing Hot melt extrusion technology

Undergraduate project – AC Tech, Anna University, Tamil Nadu, India January 2016-May 2016

• Formulation and evaluation of okra related matrix tablets for colon targeting drugs Poster Presentations

AAPS conference, Philadelphia 17th October-20

th

October2021

• Hot melt extrusion coupled pressurized carbon dioxide process: Assessment of milling efficiency and tableting properties

AAPS conference, Virtual 26th October-5th November 2020

• Investigation of Taste Masking Efficiency of Caffeine Citrate by Lipids Utilizing Hot Melt ExtrusionTechnology 71st Indian Pharmaceutical Congress, Sri Ramachandra Institute of Higher Education and Research, India December 2019

• Impact of polymeric carriers on the processability of Theophylline Nicotinamide pharmaceutical co-crystals utilizing Hot melt extrusion technology

AAPS conference, San Antonio November 2019

• Impact of polymeric carriers on the processability of Theophylline Nicotinamide pharmaceutical co-crystals utilizing Hot Melt Extrusion Technology

• Formation of Kollidon® VA-64 Based Theophylline Nicotinamide co-crystals utilizing Hot Melt Extrusion Technology School of Pharmacy Annual Poster Session, The University of Mississippi, Oxford October 2019 Investigation of Theophylline Nicotinamide pharmaceutical co-crystals utilizing Hot Melt Extrusion Technology University of Mississippi Research Day, Jackson Avenue Center, Oxford April 2019 Investigation of Theophylline Nicotinamide pharmaceutical co-crystals utilizing Hot Melt Extrusion Technology Graduate Research Symposium, Graduate School, University of Mississippi, Oxford March 2019 Investigation of Theophylline Nicotinamide pharmaceutical co-crystals utilizing Hot Melt Extrusion Technology AAPS conference, Washington DC November 2018

Development of Theophylline Nicotinamide co-crystals utilizing Hot Melt Extrusion (HME) Technology Publications

• Minjia Wang, Yusheng Li, Priyanka Srinivasan, Zhiquing Hu, Rui Wang, Anggrida Saragih, M.A.Repka, Narasimha Murthy. Interaction between biological products and product packaging and potential approaches to overcome them. October 2018. AAPS PharmSci Tech

• Priyanka Srinivasan, Mashan Almutairi, Nagireddy Dumpa, Sandeep Sarabu, Suresh Bandari, Feng Zhang, Eman Ashour, Michael A Repka. Theophylline – nicotinamide pharmaceutical co-crystals generated using hot melt extrusion technology: Impact of polymeric carriers on processability. October 2020. JDDST

• Sagar Narala, Dinesh Nyavanandi, Priyanka Srinivasan, Preethi Mandati, Suresh Bandari, Michael Repka. Pharmaceutical Co-Crystals, Salts and Co-Amorphous Systems: A Novel Opportunity of Hot Melt Extrusion. November 2020.JDDST

• Chung, Sooyeon, Priyanka Srinivasan, Peilun Zhang, Suresh Bandari, and Michael A. Repka. Development of ibuprofen tablet with polyethylene oxide using fused deposition-modeling 3D printing coupled with hot-melt extrusion. Journal of Drug Delivery Science and Technology 76 (2022): 103716.

• Almutairi, Mashan, Priyanka Srinivasan, Peilun Zhang, Fischer Austin, Arun Butreddy, Muteb Alharbi, Suresh Bandari, Eman A. Ashour, and Michael A. Repka. Hot-Melt Extrusion Coupled with Pressurized Carbon Dioxide for Enhanced Processability of Pharmaceutical Polymers and Drug Delivery Applications–An Integrated Review. International Journal of Pharmaceutics (2022): 122291.

• Muhindo, Derick, Rasha Elkanayati, Priyanka Srinivasan, Michael A. Repka, and Eman A. Ashour. Recent Advances in the Applications of Additive Manufacturing (3D Printing) in Drug Delivery: A Comprehensive Review. AAPS PharmSciTech 24, no. 2 (2023): 57.

• Srinivasan, Priyanka, Mashan Almutairi, Ahmed Adel Ali Youssef, Ahmed Almotairy, Suresh Bandari, and Michael A. Repka.

"Numerical simulation of five different screw configurations used during the preparation of hot-melt extruded Kollidon® and Soluplus® based amorphous solid dispersions containing indomethacin." Journal of Drug Delivery Science and Technology (2023): 104561.

Awards and Certifications

• Best Poster Award-First place in Pharmacy poster session, The University of Mississippi, University, Oxford

• Graduate Student Travel Award (Graduate school, The University of Mississippi, 2019)

• Advanced Certificate course in US Regulatory Affairs-Drug and Devices. (Institute of Regulatory Affairs Education and Training, 2018)

Professional Affiliations

• Member, American Association of Pharmaceutical Scientists (AAPS) (since 2017) Reviewer of the AAPS PharmSciTech journal (since 2021)- By being a part of the peer review system ensured the standards of the scientific process and provided suggestions that would enhance the quality of the manuscript

• Member, American Diabetes Association (since 2017)

• Member, Rho Chi-The Academic Honor Society in Pharmacy (since 2019) Research Lab Skills

• Hot melt extrusion: Worked on 6mm, 11mm and 16mm for lab scale extrusion studies for solid oral dosage forms

• Imaging: Characterization of powders, HME extrudates by hot stage microscopy for assessing thermal transitions and scanning electron microscopy for studying the morphology of the extrudates

• Spectroscopy: Measurement of the amount of drug released in the medium by UV spectrophotometer for in vitro drug release studies and FTIR for studying the molecular interactions in formulations

• Analytical and thermoanalytical: Assessment of thermal behavior, degradation kinetics and data analysis interpretation by DSC, TGA, XRPD and HPLC analysis for drug content and calculating % release for in vitro drug release studies

• Dissolution testing and drug release tests by USP type I and type II apparatus for solid oral dosage forms like tablets, granules and capsules

• Performed sieve analysis, bulk and tapped density for powders and granules Knowledge of GMP, USP and ICH guidelines

Other Experience

Library Student Assistant - The University of Mississippi-University, MS October 2018-August 2019 Database maintenance (OCLC, Innovative Millennium, Sierra) Metadata and Digital Initiatives Department Office Assistant - The University of Mississippi-University, MS May 2018-July 2018

• Answered and directed incoming calls to the appropriate departments

• Assisted other employees with errands and office duties

• Demonstrated customer service skills through interaction with staff and students Service and Community Engagement

Volunteer -Graduate student internship panel- The University of Mississippi, University, MS January 2022-May 2022 Volunteer - Graduate lab assistant- The University of Mississippi, University, MS 13th-14th September 2021

• Assisted students by demonstrating the fundamentals and applications of the Hot Melt Extrusion (HME) process in the Pii Center Fall 2021 workshop conducted by the department of Pharmaceutics and Drug Delivery in association with University of Mississippi-American Association of Pharmaceutical Scientists (UM-AAPS) student chapter Volunteer -Anna University, India August 2012-August 2013

• Was an active member of National Service Scheme (NSS)

• Tutored students for courses like Math, Science and Social Studies

• Assisted students in developing social skills and mobility Organizer -Anna University, India

• Worked as an organizer and was part of the editorial team in Biotechcellence, a National-level symposium

• Mapped out several methodologies by assisting the student community for their career endeavors

• Acquired leadership skills



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