Suchitra Ramachandran

Claremont, CA- ***** 909-***-**** actlka@r.postjobfree.com

EDUCATION

Keck Graduate Institute (KGI), Claremont, CA Class of 2016

Master of Bioscience, Major: Clinical and Regulatory Affairs

Courses: US Regulatory Affairs, Medical Device Regulatory affairs, Biopharmaceutical Quality Assurance and Control

Anna University, Chennai, India Class of 2010

Bachelor of Technology, Industrial Biotechnology

Courses: Biopharmaceuticals Engineering, Cell & Molecular Biology, Cancer Biology, Biochemistry, Genetic Engineering

SKILLS &LEADERSHIP

-cGMP & ICH guidelines

-Microsoft Excel, Power point, Visio

-Employee training

-Lean & Six sigma certified

PROFESSIONAL EXPERIENCE

Biocon Limited, Bangalore, India – Quality Control Analyst, Molecular biology laboratory Oct’10-Jul’14

-Performed quality release and stability testing on finished products and drug substance following ICH guidelines.

-Incepted samples stability programs using NovaTek LIMS software.

-Maintained reserve sample log and performed testing for the same on required date.

-CAPA investigation, Planned/Unplanned deviation, Change control forms on requirement.

-Preparation and review of validation and protocols, reports, method transfer reports, standard operating procedures (SOPs) and laboratory qualification reports.

Endologix, Irvine, California – Regulatory Affairs Intern Jun’15-Aug’15

-Managed working with Device tracking Form (DTF) system that include:

-Quality Assurance, Data Entry, Preparing and sending mailings of DTF’s for periodic return.

-Production/assembly of paper and electronic regulatory submissions for US filings

-Reviewed document status through Master Control for Notice of change application.

GRADUATE PROJECTS

BioMarin Pharmaceutical September’15- Present

-An environmental investigation of recurrent bleeding with Left Ventricular assist Devices in association with Von Willebrand Disease (VWD)

-Explored state of the art therapeutic approaches, patient demographics, and diagnosis of ‘recurrent ’episodes.

-Conducting KOL interviews to understand treatment options, physician preference, and patient management

-Recommend patient selections, use recruitment techniques, analyze trial size, duration, and create a model for trial.

Method validation and transfer to Pharmaceutical Product Development (PPD), Ireland April’14- June’14

-Validated and transferred a Western Blotting method for PEGylated GCSF (Granulocyte Colony Stimulation Factor) for clinical batch release in Europe.

-Ensured uniformity in procedure in India and Europe

-Resulted in a successful transfer of method and gained an understanding of global quality control.

cGMP Audit September’15 – October’15

-Performed a mock audit for a research laboratory with the goal of finding cGMP violations.

-Determined the root cause of every violation that was found.

-Prepared a CAPA report for the same.

Clinical Trial Design Feb’15-March’15

-Designed a clinical trial for Phase II studies of a male contraceptive pill to file for an NDA.

- Prepared Case Report Form (CRF), Informed consent, and a Patient’s brochure underlying the requirements of the trial

- Following regulatory advertisement and labeling conditions, conducted an advertisement for patient recruitment.

HONORS & AWARDS

-White Belt certified and Yellow belt certified – Lean and Six Sigma

-Certificate of recognition for ‘Key contribution to EHS; 41st national safety day celebration, Biocon Limited, 2012.

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