Anjali Joshi

Email: abqfle@r.postjobfree.com

Address: **** ******** ***, *** *

City: Pittsburgh

State: PA

Zip: 15216

Country: USA

Phone: 412-***-****

Skill Level: Entry

Salary Range: $60,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

CAREER GOAL: Scientist (Formulation Development/Analytical)

PERFORMANCE PROFILE:

Motivated and goal-oriented professional with strong educational background in pharmaceutical sciences and an excellent knowledge in drug product development. Experienced in preformulation studies, formulation development and manufacturing, analytical method development and validation, and clinical trials. Articulate and professional communication skills. Productive in both team-based and self-managed projects. Appreciated by colleagues for work ethics, team leadership and open-mindedness.

TECHNICAL KNOWLEDGE/SKILLS:

Preformulation, formulation development and manufacturing:

Characterization of API and excipients, drug/drug and drug/excipient compatibility studies, and screening design for excipient selections

Formulation design, development and optimization studies using suitable DoEs, prototype formulation batch to pilot scale batch manufacturing, technology transfer to CMOs for clinical trial batches

Operation of various manufacturing equipment following SOPs: roller compactor, fitz mill, co-mill, high shear granulator, low shear planetary mixer, V-blender, 38 station tablet compression unit, Hi-coater, fluid bed granulator, In-cap capsule filling machine

Analytical:

Analytical method development (HPLC-UV) and validation according to the ICH guidelines for pharmaceutical and biological samples analysis

Particle size analysis, powder flow analysis, bulk density analysis, tablet hardness testing, friability, disintegration and dissolution testing following USP compendial methods

Implementation of stability tests following ICH guidelines

Solid state characterization techniques (for APIs and excipients) such as Powder X-Ray Diffraction, FT- Infrared Spectroscopy, Differential Scanning Calorimetry, Scanning Electron Microscopy, Optical Microscopy

Clinical trials:

Documentation experience in Institutional Review Board (IRB) documents, patient informed consent form and case report forms (CRFs)

Knowledge in human clinical trials with a focus on Bioavailability/Bioequivalence(BA/BE) studies

Coordinating clinical trial drug manufacturing with CMOs

Regulatory:

Good understanding of cGMP, FDA regulations and ICH guidelines for industry

Preparing Investigational New Drug (IND) application documents and knowledge of ANDA submission

Documentation:

Writing and implementation of master batch records for various manufacturing process (granulation: dry & wet, capsule filling, tablet compression, and spray coating)

Preparation of research papers and technical reports (product development, analytical method development and validation, in-process/end-process release documents)

Computer:

Data acquisition software for Waters HPLC 2650 Module: Empower 2; PXRD: High Score Plus; Nicolet FT-IR: OMNIC; tablet processing: The Director

JMP (SAS product); WinNonLin 6.1(Pharsight Product)

Microsoft Office

PUBLICATIONS (PEER REVIEWED):

A. Joshi, M. Adeyeye. (2012) Reversed phase LC-UV method development and validation for simultaneous determination of three antiretrovirals: lamivudine, zidovudine, nevirapine and possible degradants in a fixed dose pharmaceutical product. Journal of Pharmaceutical Technology and Drug Research, 1:1-8

F. Esseku, A. Joshi, Y. Oyegbile, G. Edowhorhu, D. Gbadero, M. Adeyeye. (2012) A randomized Phase I bioequivalence clinical trial of a pediatric fixed-dose combination antiretroviral reconstitutable suspension in healthy adult volunteers. Antiviral Therapy (Doi: 10.3851/IMP2310)

A. Joshi, F. Esseku, L. Silva, C. Igwilo, D. Oqua, B. Kunle, O. Obodozie, U. Inyang, M. Adeyeye. (2010) Post-marketing in-vitro/in-vivo Assessment of fixed dose combination products of first line antiretrovirals. Journal of Pharmaceutical Sciences.99 (6):2655-2663

A. Joshi (Shrestha), P. Thapa. (2004) In-vitro Evaluation of Controlled Release Diclofenac Potassium Biphasic Matrix Tablet. Journal of Nepal Pharmaceutical Association. XXII (1):26-39 ISBN 0253-8261

PATENT:

Moji Adeyeye, Fred Esseku and Anjali Joshi. Antiretroviral drug formulations for treatment of children exposed to HIV/AIDS. US Patent-201*-*******-A1 May 19, 2011

EXPERIENCE:

Research Assistant, Duquesne University (2006-2011)

Developed/validated and successfully implemented RP-HPLC-UV method for simultaneous determination of three antiretroviral drugs (Pharmaceutical and Biological Samples Analysis); Designed and executed experiments to develop a robust fixed dose combination ODT product comprising three APIs; Planned and implemented suitable DoEs during preformulation and formulation studies; Scaled up prototype formulation to pilot cGMP clinical batches for clinical trials; Performed accelerated stability studies according to ICH guidelines; Developed Institutional Review Board (IRB) and clinical trial protocol documents approved by IRB committees; Assessed bioequivalence of the product developed in healthy human volunteers with successful outcomes

Teaching Assistant, Duquesne University (2006-2012)

Assisted in facilitating compounding pharmacy labs: Pharm D. course; Assisted as a head teaching assistant in coordinating TAs schedules, organizing meetings and improving course materials; Assisted in manufacturing pharmacy graduate course, prepared and implemented batch manufacturing records (BMR) for different manufacturing operations

Lecturer, Kathmandu University, Nepal (2004-2005)

Taught courses in industrial pharmacy and microbiology; Co-ordinated microbiology labs and supervised B.Pharm project works

Intern (Production), Royal Drugs Limited, Kathmandu, Nepal (2004)

Involved in solid oral drug product manufacturing

PRESENTATIONS (NATIONAL AND INTERNATIONAL MEETINGS):

Anjali Joshi, Fred Esseku, Daniel Gbadero, Fikayo Adesanya, Moji Adeyeye. Bioequivalence Assessment of Zidovudine/Lamivudine/Nevirapine Fixed-Dose Combination Fast-Disintegrating Tablet: An Open-label, Randomized, Two-way Cross-Over Study in Healthy Volunteers. AAPS, 2011

Anjali Joshi, Moji Adeyeye. Optimization of Directly Compressed Orally Disintegrating Tablets (ODTs) containing High Drug Load using a Response Surface Design. AAPS, 2010

Anjali Joshi, Fred Esseku, Moji Adeyeye. Development of Stability-indicating Reversed Phase HPLC-UV Method for Simultaneous Determination of Antiretroviral Drugs in a Fixed Dose Combination (FDC) Pharmaceutical Formulation. AAPS, 2009

Anjali Joshi, Fred Esseku, Lanre Silva, Cecilia Igwilo and Moji Adeyeye. Use of WinNonLin(R) Software to Assess Bioequivalence of Fixed dose-combination Antiretroviral (ARV) Drug Products (zidovudine/lamivudine) Marketed in West Africa. XVII International AIDS Conference, 2008

AWARDS:

Travelship Award, 2010 FIP Pharmaceutical Sciences World Congress /AAPS

APQ Travelship Award, 2009 AAPS Annual Meeting & Exposition

Ratna Vidhya Padak III, and Tuborg Excellency Award, 1993 (nationwide), High School Board Exam

PROFESSIONAL AFFILIATIONS:

Member: AAPS (2007-Present)

Secretary: AAPS Duquesne University Student Chapter (2008-2009)

EDUCATION:

M.S in Pharmaceutics

Duquesne University, Pittsburgh, PA 15282

Masters in Pharmacy

Bachelors in Pharmacy

Kathmandu University, Nepal

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