Shanta R. Bhattarai

Technical Steward and senior pharmaceutical scientist with 19+ years of experience advancing complex drug product technologies from R&D through commercial manufacturing. Expert in oral solid and advanced oral delivery systems (SoftGel, LiquiSoft, Chewels), process development, scale-up/scale-down, validation, technology transfer, and cGMP manufacturing science. Proven ability to serve as site SME, single point of contact (SPOC) for MS&T and global technical networks, and steward technical standards across equipment, processes, and lifecycle stages.

Strong record of leading DoE-based optimization, technical investigations, CAPA/RCA, risk assessments, and continuous improvement initiatives. Ph.D. in Physical Sciences & Engineering with deep expertise in pharmaceutics, biochemical engineering, nanotechnology, and analytical characterization. Recognized for cross-functional leadership, scientific rigor, and technical governance in CDMO and large-scale manufacturing environments.

CDMO R&D Lead / Manufacturing - Thermo Fisher Scientific - High Point, NC

(2021-01)

• Served as technical owner for SoftGel, LiquiSoft, and Chewels processes, ensuring robust scale-up, reproducibility, and commercial readiness.
• Acted as SPOC between R&D, MS&T, Engineering, QA, and Operations for technology transfer and process governance.
• Led pilot-scale, scale-up, and scale-down studies to establish process capability and define technical standards.
• Designed and executed DoE-based process development, optimization, and validation protocols.
• Supported equipment selection, qualification, and validation for new technologies and capital projects.
• Directed technical investigations, deviations, CAPA, and RCA to resolve manufacturing challenges.
• Authored and reviewed batch records, validation protocols, risk assessments, SOPs, and technical reports.
• Provided technical training and strengthened site capabilities through structured knowledge transfer.
• Collaborated with global teams to evaluate and implement new technologies and technical standards.
• Led cross-functional teams across Innovation, Product Development, R&D, and Technical Operations.

R&D Formulation Scientist III - Thermo Fisher Scientific - High Point, NC

(2022-01 - 2024-12)

• Developed innovative oral formulations using blending, encapsulation, suspensions, lipid emulsions, and softgel technologies.
• Conducted secondary scientific review to ensure technical accuracy and compliance with site standards.
• Evaluated emerging technologies to expand manufacturing capabilities and maintain state-of-the-art processes.
• Led continuous improvement initiatives and trained junior scientists on technical best practices.
• Supported client interactions, technical presentations, proposals, and change orders.

R&D/Mfg Scientist - Thermo Fisher Scientific - High Point, NC

(2021-01 - 2022-12)

• Executed process development for feasibility, pivotal, and late-stage manufacturing using statistical tools and DoE.
• Applied PAT tools and QbD approaches to monitor continuous manufacturing.
• Led preparation and review of GMP documentation, change controls, deviations, and risk assessments.
• Supported CMC documentation for NDA/ANDA submissions.
• Partnered with QA, Regulatory, Engineering, and Operations for successful tech transfer and validation.

Principal Investigator / Visiting Faculty / Adjunct Assistant Professor - North Carolina A&T State University & UNC Greensboro

(2018-01 - 2021-12)

• Led formulation development of LNPs, polymeric delivery systems, and fibrous drug particulates.
• Directed analytical characterization (DLS/ELS, microscopy, spectroscopy, HPLC).
• Designed 3D cell culture matrices and biomaterials for drug toxicity and bioanalytical studies.
• Supervised graduate students and delivered advanced coursework in drug design and delivery.

Senior Research Scientist / Instructor / Assistant Professor - UT MD Anderson Cancer Center & University of Houston

(2012-01 - 2017-12)

• Led formulation and analytical development of injectable nanomaterials and targeted delivery systems.
• Applied DOE, QbD, and biophysical characterization to support preclinical development.
• Collaborated with CMC and regulatory teams for IND/NDA/BLA documentation.

Research Scientist / Postdoctoral Fellow - Children's Hospital Oakland Research Institute & Wayne State University

(2007-01 - 2012-12)

• Developed non-viral gene/drug delivery platforms and analytical assays.
• Led nanoparticle formulation, characterization, and biological evaluation.

Postdoctoral - Bio-Engineering & Pharmaceutics - UC Berkeley and CHORI

Postdoctoral - Pharmaceutics - Wayne State University

Ph.D./M.S. - Bio-Chemical Engineering & Pharmaceutics - Chonbuk National University