Deepthi Sudhir Keni

About Deepthi Sudhir Keni

I am passionate Biotechnology engineer with a Master\'s degree in Pharmaceutical Sciences from University of Massachusetts, Lowell. Currently I am working as Quality Control Stability study analyst at Vaxart.Inc, South San Francisco, California. I manage about 20 on going Stability studies for Vaxart Products. I work with QC analytical team and external vendors to ensure the stability testing is completed on time. I work with sample management to ensure stability samples are pulled on time. I create Interim and final stability reports. I create new stability protocol and revise the existing ones for better understanding. I perform data trending of stability data. I resolve any deviations/events/OOS/CAPAs results from the stability results.Previously, I worked as a Stability study supervisor at SEQENS, Newburyport, Massachusetts. I was responsible for conducting GMP stability study for 30 on-going batch. I wrote SOP for new stability products in compliance with GDP. I managed the full Stability program and performed technical data review and wrote Interim reports. I also communicated with the Quality control department regarding the analytical testing of the sample to meet the timeline of the study. I performed investigation of Quality events such as Laboratory Investigation and Quality Investigation for Out of Specifications and Out of Trend results to determine the root cause using the 5 why or Fishbone method and assign related corrective action with CAPA’s. I was responsible to write Change Control for retest date extension of API’s in compliance with FDA and ICH guidelines. At Seqens, I also worked as Control Analyst performing In-Process sample analysis, Finished product testing, raw materials testing, Reference standard qualification and stability studies. I have operated analytical instruments such as HPLC, GC, FT-IR, UV-VIS, KF analysis, Polarimeter and Malvern Particle size analyzer. I have successfully performed Cleaning Validation of various API. I am able to document all analysis performed as per SOP.I have a good communication, management, and organizational skills.

Experience

1. Quality Control Analyst Stability Study

   Vaxart, Inc.

   May 2022 — Present · US

   Manage Quality Control stability program for Vaxart products.• Ensure existing stability program is executed per protocol. • Work with QC Analytical team and external vendors to ensure that stability testing is completed on time. • Work with Sample Management to ensure stability samples are pulled on time.• Create interim and final stability reports.• Create additional stability studies as needed.• Ensure stability equipment is properly qualified and maintained. • Perform data trending of stability data. • Resolve any deviations/events/OOS/CAPAs resulting from stability results.

Education

• University of Massachusetts Lowell

  Master's degree, Pharmaceutical Sciences

  2016 — 2018

• Maharani Lakshmi Ammani Womens College, 18th Cross, Malleshwaram, Bangalore 12

  Research intern

• University of Massachusetts Lowell

  Research Intern, Pharmaceutical Analysis

  2018 — 2018

• careers for BANGALORE

  Bachelor's degree, Biotechnology

  2011 — 2016