Summary
Overview
Work History
Education
Skills
Websites
Certification
https://www.linkedin.com/in/deepika-vippagunta-159a7018/
Timeline
Generic

Deepika Vippagunta

Summary

Forward-thinking Senior Manager adept at managing teams of 80 employees with 4 direct reports to accomplish challenging objectives. Imparts clear vision to guide cohesive, high-performing teams. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Senior Manager, Process Analytics Technical Service

Sarepta Therapeutics
Burlington, MA
01.2022 - Current

· Management of Process Analytics group to generate high-quality, robust, and reliable analytical data to accelerate the development activities of the Tech Ops department by supporting in-process, DS & DP sample testing for product & process characterization.· Ensure members of the process analytics group are suitably trained to independently perform complex data analysis and keep detailed electronic notebook records.· Support the Analytical Development team in the troubleshooting and implementation of new technologies and assays.· Participate in and oversee method development and qualification activities for various analytical methods.· Preparation, qualification, and management of critical reagents for lifecycle management (LCM) of various assays for consistently reproducible data.· Managing laboratory infrastructure (Analytical Equipment, Freezers, etc.) for the optimal performance of the Process Analytics team.· Lead external interactions as SME with CROs / CMOs in matters of Tech Transfer, assay establishment, optimization, troubleshooting, and qualification.· Lead method transfer and qualification activities from non-GMP to GMP labs and associated activities.· Authoring, reviewing, and approving technical documents (e.g., SOPs, protocols, reports, CoA, CoT, memorandums, etc.) that support IND/CTA submissions.· Participate in Quality Event Risk Assessment as a functional SME, and assist in CAPA and other related activities.· Organizing and communicating data to key stakeholders.· Presenting data in cross-functional team meetings and monthly metrics with sample TAT etc. for senior leaders.· Improved the throughput & turnaround times for sample testing year over year (year-1, 80%, Year-2, 40%) by being a key player in the progression of program deliverables by aiding in the generation of robust & reliable data.

  • Achieved operational excellence by streamlining processes and implementing best practices.
  • Improved team performance by providing comprehensive training and fostering a collaborative work environment.
  • Consistently met or exceeded annual performance targets set by senior leadership.
  • Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
  • Boosted team member productivity by enhancing performance monitoring and instituting motivational approaches.
  • Provided strong leadership to enhance team productivity and morale.

Scientist, BioAnalytics, Analytical Development

Takeda Pharmaceuticals
Lexington, MA
07.2020 - 01.2022
· Support Early and Late-stage products both in-house and outsourced programs as an SME for QPCR-based methods.· Development and Qualification of QPCR and ELISA-based methods.· Training multiple analysts across the organization (IPA, AD, Cell Therapy Teams) on QPCR & ELISA assays.· Prepare and qualify critical reagents and general lab management.· Authoring Development & Qualification reports.· Authoring IND and BLA sections for the relevant methods.· Lead methods transfer and validation activities at CDMOs.

Senior Development Specialist, Process Analytics

Shire Pharmaceuticals
Lexington, MA
09.2018 - 07.2020
· Provided analytical support for upstream, downstream, pilot, and formulation development teams.· Mentored and guided a couple of contractors in training, reviewing data, guidance to set up non-routine experiments, and handling technical issues.· Trained new analysts in analytical methods.· Design and execute routine & non-routine analytical assays.· Provide process samples testing data promptly.· Work with matrix teams for assay transfer and troubleshooting assays.· Strong experience in process and product characterization using wide range of analytical techniques like QPCR (Human DNA, CHO DNA, E. coli), Octet (Red 384, HTX), CE-SDS (LabChip GXII, LabChip Touch), HPLC-SEC (Waters), HPLC-RP (Waters), Glycan Mapping, Amino Acid Analysis, Pro A Titer, SoloVPE (A280), with a weekly turnaround of ~200 samples.· Maintain lab notebooks, and report data adhering to timelines.· Analyzing, trending, and documenting the experimental results in Lab Notebooks, reporting the results of analytical testing to cross-functional teams, and presenting the data in group meetings.· Working as an IPA representative for early phase molecules, by attending technical meetings with upstream, downstream, and analytical development teams, communicating the studies being performed, testing requirements to the IPA team, compiling, and trending the analytical data from the analytical testing and reporting it to stakeholders and a significant contributor for project progression.· Working as an IPA representative for the MAM-MS technology working group, to develop multi-attribute mass spectrometry methods to reduce the analyst time in testing in partnership with the characterization group.

Research Associate(Contract)

PRO Unlimited (Sanofi)
Framingham, MA
08.2016 - 06.2018
· Responsible for 50% of the sample volume testing supported by the team for upstream, and downstream process development, formulation development teams with sample testing of in-process samples, drug substance and drug product samples for identification of critical process parameters and critical quality attributes for products in preclinical and clinical development, and commercial products.· Support upstream, cell line development team by analytical testing using Octet biolayer interferometry (Octet QK 384) for clone selection and process optimization.· Developed and qualified Octet titer methods for antibodies, FC fusion proteins, and Fab antibodies, to support clone selection and process optimization.· Determination of aggregation and purity using SEC-HPLC (Agilent), RP-HPLC (Agilent), and CE-SDS (Beckman Coulter PA 800+) of various process intermediates, drug substances, and drug products.· Perform various platform methods of ELISA to determine Host Cell protein impurities of in-process and drug substance samples and qualification of new sample types.· Analyzing, trending, and documenting the experimental results in Electronic Lab Notebooks, reporting the results of analytical testing to cross-functional teams, and presenting the data in group meetings.

Research Assistant

Indian Institute of Chemical Technology
06.2006 - 03.2007
  • Developed methods for the Sulfonation of hydrophobic molecules including naturally occurring oils and fats.
  • Successfully developed methods for the softening of leather and its related products.
  • Developed efficient methods of drug-polymer conjugates using a variety of reactions including activated ester approach, oxidation and epoxidation.
  • Proficient in interpreting the NMR and IR Spectral data to deduce the chemical structures for a variety of molecules of biological interest.
  • Expert in the development of column chromatographic methods for the purification of biomaterials and pharmaceutical intermediates.
  • Familiar with the routine analytical methods such as HPLC, GC-MS, UV-Vis, FT-IR and NMR.
  • Presented the scientific data to middle managers in group meetings.

Assistant Lecturer

Sri Chaitanya Educational Institutions
06.2005 - 06.2006
  • Taught chemistry to undergraduate students.
  • Conduct laboratory classes.
  • Provided Guidance to various Engineering and Medical aspirants.
  • Advised students on academic plan and course selection.

Education

Master of Science - Biotechnology

Framingham State University
Framingham, MA
05.2018

MS - Organic Chemistry

Osmania University
Hyderabad
2005

BS - Microbiology, Genetics, Chemistry

Osmania University
Hyderabad
2003

Skills

    Analytical Development

    Tech Transfer

    Method Qualification/validation

    Life Cycle Management (LCM)

    ICH Q14, ICH Q2R2, ICH Q12

    GMP Process/Documentation

    SOP Authoring, Review & Approval

    Team Management

    Cross-Functional Communication

    Operational excellence

    Startegic Thinking

Certification

Certificate in ICH-GCP (principles of GCP- Guideline E6), Biopharma Institute, June 2015.Certificate in GMP (Documentation and Record Keeping), Biopharma Institute, June, 2015.Certificate in Drug Safety and Pharmacovigilance, Biopharma Institute, March, 2016.

https://www.linkedin.com/in/deepika-vippagunta-159a7018/

A disciplined Bioanalytical Scientist with 9 years of experience, strong analytical skills and expertise working with Glycan Mapping (Dionex),HPLC-SEC, HPLC-RP (Agilent, Water's), UPLC (Water's), CE-SDS (PA 800 plus, LabChip GXII, LabChip Touch), Octet for Capsid titer(QK 384, Red 384, HTX, RED96e), QPCR ( Kingfisher Flex, LightCycler 480,Applied Biosystems™ 7500), ddPCR (Bio-Rad) dPCR (Qiacuity), CIEF (Maurice), TECAN Fluent, GC-MS, UV-Visible, FT-IR, column chromatography, ELISA and wet chemistry analysis. Expertise in inline monitoring of critical quality attributes (CQA's) and development of Impurity quantification assays for various therapeutic modalities including Cell & Gene Therapy products, Antibodies, Fusion Proteins and Enzymes. Experience with authoring relevant analytical sections for IND and BLA filing. Good knowledge of GMP, ICH guidelines & FDA regulations.

Timeline

Senior Manager, Process Analytics Technical Service

Sarepta Therapeutics
01.2022 - Current

Scientist, BioAnalytics, Analytical Development

Takeda Pharmaceuticals
07.2020 - 01.2022

Senior Development Specialist, Process Analytics

Shire Pharmaceuticals
09.2018 - 07.2020

Research Associate(Contract)

PRO Unlimited (Sanofi)
08.2016 - 06.2018

Research Assistant

Indian Institute of Chemical Technology
06.2006 - 03.2007

Assistant Lecturer

Sri Chaitanya Educational Institutions
06.2005 - 06.2006

Master of Science - Biotechnology

Framingham State University

MS - Organic Chemistry

Osmania University

BS - Microbiology, Genetics, Chemistry

Osmania University
Deepika Vippagunta