Supply Chain Design

Kushal R. Desai (B.Pharm., M.S.)

**** ** ***** ****, *** K, Kansas City, MO - 64154

***********@*****.*** Phone: 443-***-****

Clinical Pharmacist and Bioscience Regulatory Affairs graduate with strong background in QA/QC, GMP, FDA and NIH regulations, seeking industry opportunities in clinical trials, drug licensing and regulations.

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Education

Johns Hopkins University Jan-2010- Dec-2011

Master of Science in Bioscience Regulatory Affairs Baltimore, Maryland

GPA – 3.81

Rajiv Gandhi University of Health Sciences, School of Pharmacy Sept 2004- Oct 2008

Bachelor of Pharmacy Bangalore, India

GPA – 3.75

________________________________________Work/Laboratory Experience

Specialist, Regulatory Compliance, Nostrum Laboratories Inc. May 2012 - Present

• Preparation, compilation and review of the regulatory submissions, which include: ANDAs, amendments, supplements (ex.,CBE, PAS), annual reports, adverse drug effects, quarterly reports, annual reports, state licenses, labeling compliance, electronic submission of label changes

• Follow and apply requirements of batch records, SOPs, test methods, validation protocols, validation reports, calibration, and change control records to administer quality and compliance into processes used by Nostrum Laboratories, Inc.

• Handle deviations, OOS, Investigations and CAPA(s) to support production and laboratory.

• Facilitate during FDA inspections, prepare, and review FDA related and relevant communication.

• Assist in FDA/external/internal audits as required

Regulatory Operations Intern, Nostrum Laboratories Inc. Jan 2012 – April 2012

• Preparation, and review FDA related and relevant communication.

• Apply principles outlined in CFR, ICH, and FDA guidelines.

• Collaborate with Quality, Manufacturing, Validation, Maintenance, Technical Services, Supply Chain, and Lab Management to ensure unfavorable trends are identified and resolved.

• Obtaining and maintaining state and FDA licenses.

• Obtaining new or revised labels and package inserts.

• Handling adverse drug experience reports.

• Regulatory Project Management.

Research Assistant, Brady Urology Laboratory, Johns Hopkins Medicine. April 2010-Dec 2011

Regulatory Duties/Medical Writing

• Complete IND protocol design and submission to the FDA for a prostate specific marker developed by the laboratory.

• Present at Exploratory IND meetings with the FDA.

• Prepare Chemistry, Manufacturing and Control (CMC) documentation according to the FDA guidance.

• Prepare e-IRB protocol for YC-27 compound developed for use during prostatectomy.

• Provide assistance in writing, compiling and submissions of research grants inclusive of NIH, DOD, federal and private foundations grants like Patrick C Walsh grant.

• Prepare CMC submissions in Common Technical Document (CTD) format.

Research/Laboratory Duties

• Develop and translate adenoviral gene therapy vectors for the treatment of local and advance prostate cancer.

• Study the role of microRNA’s in the regulation of androgen dependent and androgen independent prostate cancer and benign prostatic hyperplasia.

• Perform various techniques like Western Blot, PCR, colony PCR, Miniprep, Maxiprep, Virus amplification and purification.

Student Assistant: Student Employment Services – Johns Hopkins University Feb 2010-April 2010________________________________________

Relevant Coursework at Johns Hopkins University

Product Development: from Intellectual Property to Licensing, Clinical trial: Design and Conduct, Food & Drug Law, Clinical Development of Drugs and Biologics, Bioinformatics, Practicum in Regulatory Affairs, Biostatistics.

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Presentations

• Seminar (presented): Phase III Clinical Trial Study Design (Non-small cell lung cancer drug), Johns Hopkins University, Baltimore, MD

• Study Design and Complete Protocol Design of a Phase II Clinical trial drug for Asthma, Johns Hopkins University, Baltimore, MD

• Seminar (presented): Product Development Design from Screening to Post Marketing Surveillance of a Malaria Vaccine (MalariaRX), Johns Hopkins University, Baltimore, MD

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Skills

• Filing IND/BLA/NDA applications.

• Write IRB protocols and related submissions.

• Thorough ICH/GCP guidelines for human research – Advanced knowledge.

• Scientific visual representation by CIRCOS ware.

• Bioinformatics Databases like GenBank, EMBL, DDBJ, Ensemble, SwissProt, Pfam, SCOP, CATH, OMIM, Entrez (NCBI), and EXPASY (Expertise – Advanced).

• Sequence Analysis by BLAST suite, FASTA, CLUSTALW (Expertise – Advanced).

• Advanced computational skills including programming by Python, Perl, Java and Microsoft Office.

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