Open To Work
Deepika Vippagunta
Southborough
Summary
Strategic biopharmaceutical leader with 10+ years of experience and deep technical expertise in analytical method development, including HPLC, UPLC, CE-SDS analysis, qPCR, ddPCR, Potency, TCID50, ELISA, Octet (BLI), AUC, and a broad range of analytical methods for process and product characterization. Proven track record in method development, transfers, and validation with technical excellence, and leading cross-functional collaborations working with CDMO/CRO/CTO. Adept at driving biologics & gene therapy programs from development to clinical stages. Recognized for leadership, analytical problem-solving, team management and authoring IND/CTA/BLA documentation and relevant CMC sections.
Overview
10
10
years of professional experience
Work History
Associate Director Process Analytics Technical Services/Analytical Development
Sarepta Therapeutics
03.2025 - 07.2025
- Led and mentored a team of 5+ scientists supporting analytical development and high throughput testing of multiple methods including HPLC-SEC, CE-SDS analysis, cell-based, biophysical, Octet (BLI), ELISA's and PCR-based methods, fostering professional growth and high team performance.
- Drove analytical deliverables for six gene therapy programs across early to late clinical phases, enabling timely IND/BLA submissions and regulatory interactions.
- Developed and executed analytical strategies aligned with program objectives, accelerating manufacturing process development and clinical readiness.
- Collaborated across Research, Development, and broader CMC functions to solve complex drug development challenges. Represented Process Analytics on cross-functional teams and act as a key liaison managing CDMO/CRO/CTO interactions for phase appropriate analytical deliverables.
- Ensured analytical work meets cGMP and regulatory standards, supporting authoring of analytical CMC sections, method development reports and approving validation protocols, validation reports and associated documentation for filing.
- Authored, reviewed, and approved a broad range of documentation, including test methods, qualification reports, CMC sections, product characterization, analytical comparability, specification reports, COAs, deviations, and CAPAs.
- Championed initiatives that reduced complexity, improved scalability, and aligned with strategic goals across the Tech Ops organization.
Senior Manager Process Analytics Technical Services/Analytical Development
Sarepta Therapeutics
01.2022 - 02.2025
- Led strategic planning and execution for analytical development across multiple gene therapy programs, enabling advancement of programs through the testing of 800-1200 samples/month with an industry-leading 3-day turnaround time (TAT).
- Managed a team of technical specialists responsible for developing and implementing analytical methods to support product and process characterization.
- Designed and directed robust testing strategies for process characterization and stability studies, enhancing process understanding and control strategies for clinical manufacturing.
- Instituted best practices in sample submission, testing workflows, data capture, and integrity-driving improvements in notebook documentation, reporting standards, and team training.
- Oversaw qualification of critical reagents, control bridging studies, and control charting to ensure assay robustness across a wide array of methods including HPLC-SEC, HILIC-Glycan analysis, CE-SDS, AUC, ELISA, Potency, PCR, Jess-Western, Potency and impurity assays-aligned with ICHQ2R2 guidelines.
- Directed method transfer from non-GMP to GMP labs for IPC, DS and DP testing. Supported method qualification/validation at internal sites and external CRO/CTO in compliance with cGMP.
- Authored, reviewed, and approved technical documents including study protocols, reports and analytical CMC sections. Contributed to regulatory submissions in collaboration with CMC and cross-functional teams.
- Maintained analytical instrumentation and managed freezer assets, including preventive maintenance and compliance controls.
Scientist, Bioanalytics/Analytical Development
Takeda Pharmaceuticals
07.2020 - 01.2022
- Successfully developed, qualified, and transferred qPCR and ELISA methods for impurity quantification to QC labs ahead of schedule, enabling timely support of critical clinical programs.
- Subject Matter Expert (SME) for qPCR, HPLC and ELISA-based methods to quantify process and product impurities supporting both early- and late-stage programs across internal teams and external partners.
- Trained cross-functional team members across Process Analytics, Analytical Development, and Cell Therapy teams on execution and troubleshooting of qPCR and ELISA assays, strengthening analytical capabilities across the organization.
- Partnered with QC to prepare and qualify critical reagents for GMP release testing, ensuring supply readiness and regulatory compliance.
- Authored Method Development and Qualification Reports supporting IND and BLA filings; contributed directly to regulatory submission content and responded to health authority inquiries.
- Led method transfer and validation activities at CRO/CTO, ensuring successful establishment of methods for IPC and release testing in alignment with regulatory and program timelines.
Senior Development Specialist/Analytical Development
Takeda Pharmaceuticals
09.2018 - 07.2020
- Provided analytical support for upstream/downstream development; processed ~200 samples weekly using broad range of analytical methods.
- Analytical lead for early-phase programs; presented analytical findings that informed key study decisions for process and product optimization.
- Trained and mentored 2 contractors and managed non-routine and routine assay execution for 8+ programs including antibodies and enzymes.
- Acquired deep technical expertise in a wide array of analytical platforms, including HPLC-SEC/RP (Waters), Glycan Analysis, Amino Acid Analysis, Protein A Titer, Octet (Red384, HTX), CE-SDS (LabChip GXII, Touch), qPCR (Human/CHO/E. coli DNA), and SoloVPE (A280), supporting multiple programs.
Research Associate (contract)/Analytical Development
Sanofi
08.2016 - 06.2018
- Performed 50% of total sample testing volume (~8,000 samples) across upstream/downstream process development and formulation teams, supporting preclinical, clinical, and commercial programs.
- Conducted analytical testing on in-process, drug substance, and drug product samples to identify critical process parameters (CPPs) and critical quality attributes (CQAs).
- Executed key analytical techniques such as SEC-HPLC, RP-HPLC (Agilent), and CE-SDS (Beckman Coulter PA 800+) for product characterization.
- Executed platform and custom ELISA assays for product and process related impurity testing like HCP, BSA and AAVx ligand leakage.
- Trended and documented data in Electronic Lab Notebooks (ELN).
Education
PSM - Biotechnology
Framingham State University
Framingham, MAMS - Organic Chemistry
Osmania University
Hyderabad, IndiaBS - Microbiology, Genetics, Chemistry
Osmania University
Hyderabad, IndiaSkills
- ICH Q2R2, ICH Q14, USP
- Potency
- Infectivity (TCID50)
- HPLC and UPLC
- Size exclusion chromatography
- Reversed phase chromatography
- Hydrophilic interaction chromatography
- Capillary electrophoresis SDS (CE-SDS)
- Analytical ultracentrifugation
- Octet BLI technology
- Digital droplet PCR
- Droplet PCR and quantitative PCR
- Enzyme-linked immunosorbent assay
- Western blotting techniques
- Electronic lab notebook management
- Laboratory information management systems
- Veeva Vault and RIMS solutions
- IND, CTA, and BLA authoring
Work Preference
Work Type
Full TimeContract WorkPart TimeLocation Preference
RemoteHybridOn-SiteTimeline
Associate Director Process Analytics Technical Services/Analytical Development
Sarepta Therapeutics
03.2025 - 07.2025
Senior Manager Process Analytics Technical Services/Analytical Development
Sarepta Therapeutics
01.2022 - 02.2025
Scientist, Bioanalytics/Analytical Development
Takeda Pharmaceuticals
07.2020 - 01.2022
Senior Development Specialist/Analytical Development
Takeda Pharmaceuticals
09.2018 - 07.2020
Research Associate (contract)/Analytical Development
Sanofi
08.2016 - 06.2018
PSM - Biotechnology
Framingham State University
MS - Organic Chemistry
Osmania University
BS - Microbiology, Genetics, Chemistry
Osmania University