Summary
Overview
Work History
Education
Skills
Timeline
Generic

UDAY KRISHNA UPPALAPATI

Senior Chemist (QC Lead)
Raleigh,North Carolina

Summary

Senior Chemist works with leadership experience and laboratory compliance expertise, with significant experience in GMP testing for different types of chemical compounds and materials with a collaborative attitude and demonstrated ability working with global peers and cross-functional teams to deliver department and company goals.

Overview

13
13
years of professional experience

Work History

Senior Chemist (QC Lead)

Novartis
08.2020 - Current
  • Lead flexible testing team of chemists for execution of commercial release, investigative, validation, filing and stability testing.
  • Served as technical resource and compliance expert, ensuring that organizational business and compliance requirements are met.
  • Lead chemist for laboratory data review, audit trial verification, testing system e-compliance and data integrity monitoring.
  • Monitored, tracked and published lab performance metrics like RFT, Human error%, recurring deviations, overdue deviations, Escalations and Back-order values.
  • Investigated Quality control related events, OOS/OOT/OOE deviations and identified root causes. Provided quality oversight in development of appropriate CAPAs.
  • Written and reviewed stability trend reports for drug product stability studies and analytical method development activities.
  • Authored, reviewed and approved analytical testing methods, lab related SOPs, protocols and reports.
  • Performed method development and method validation activities in support of current commercial products and new products.
  • Performed project management of complex process validation and FDA filing testing projects to ensure activities successfully completed within aggressive business and compliance timelines.
  • Created weekly work schedule for team members to execute stability and finished product testing.
  • Lead weekly lab safety meetings to ensure safe handling of hazardous chemicals during testing and proper disposal after use.
  • Mentored junior chemists, fostering collaborative and supportive work environment.

QC Chemist I, II, III

Novartis
08.2013 - 07.2020
  • Performed analysis of pharmaceutical drug samples using dissolution apparatus, UV/Vis Spectrophotometer, Karl Fischer, FTIR, GC and HPLC.
  • Performed Cleaning validation analysis of pharmaceutical manufacturing equipment using Ion Chromatography and HPLC.
  • Reviewed QC data applicable to batch production and provided quality review necessary for release of raw materials and finished products as certified auditor.
  • Cross trained in multiple areas across laboratory and supported Quality control during regulatory inspections and in maintenance of state of inspection readiness.
  • Identified and implemented continuous improvement initiatives and participated in improvement activities.
  • Contributed to cost reduction efforts by identifying opportunities for reagent reuse or alternative testing methodologies without compromising accuracy or reliability of results.
  • Served as subject matter expert on chemistry-related topics during audits or customer visits, demonstrating company's commitment to excellence in quality control practices.
  • Trained junior chemists on proper laboratory procedures, instrumentation use, and data interpretation, fostering collaborative work environment.
  • Trained and certified on AQL and line inspection as part of IPQA training.

GMP Researcher and Teaching Assistant

Pharmaceutical Education And Research Center, PERC
08.2011 - 05.2013
  • Performed method development and validation for pharmaceutical compounds utilizing HPLC and UPLC technology.
  • Worked as teaching assistant for analytical instrumentation and advanced pharmaceutical analysis/spectroscopy labs.
  • Maintained detailed records of experimental procedures, observations, and results for accurate reporting and replication purposes.
  • Reviewed technical and professional publications and journals to stay current on recent literature and make more strategic research decisions.

Education

Master of Science - Pharmaceutical Sciences

Campbell University College of Pharmacy
Buies Creek, North Carolina
05.2013

Bachelor of Science - Pharmaceutical Sciences

Acharya Nagarjuna University
Guntur, India
05.2010

Skills

  • HPLC
  • GC
  • LCMS
  • Empower Software (Version 3)
  • LIMS Software
  • X- Calibur 201(HPLC-MS Software)
  • Lab Solutions (UHPLC Software)
  • Chromeleon (IC Software)
  • Trackwise
  • JMP (DOE Statistical Software
  • Microsoft office programs (Word, Excel, and Power point)

Timeline

Senior Chemist (QC Lead)

Novartis
08.2020 - Current

QC Chemist I, II, III

Novartis
08.2013 - 07.2020

GMP Researcher and Teaching Assistant

Pharmaceutical Education And Research Center, PERC
08.2011 - 05.2013

Master of Science - Pharmaceutical Sciences

Campbell University College of Pharmacy

Bachelor of Science - Pharmaceutical Sciences

Acharya Nagarjuna University

Similar Profiles

CREATE PROFILE
UDAY KRISHNA UPPALAPATISenior Chemist (QC Lead)