Collegeville, Pennsylvania, United States
Recognized technical, strategic, and people leader with deep expertise in pharmaceutical product development across long‑acting injectables (LAIs), oral solid doses (OSDs), and oligonucleotides. I specialize in integrating formulation science, process engineering, materials science, and predictive tools to build robust, scalable, and patient‑centric drug products. I have a proven track record delivering CMC programs from concept to launch — leading end‑to‑end development, platform and capability building, scale‑up, tech transfer to GMP pilot, commercial and external sites, CDMO engagement, and contributions to regulatory filings. As a people‑first leader, I’m passionate about developing talent, empowering teams, and creating environments where technical excellence and innovation thrive. I’ve led high‑performing groups across modalities, built new capabilities, and coached scientists into impactful leadership roles. Specialties: Pharmaceutical Technology • Formulation & Process Development • Process Engineering • Materials Science • Predictive Modeling • PAT • Continuous Manufacturing • Capability Building • People Leadership • Cross‑Functional Strategy
People leadership & team development - Led and developed a team of 6-8 scientists delivering end‑to‑end process and platform development, scale‑up, and tech transfer for GSK & ViiV's sterile assets from discovery through commercial readiness. ✓ Portfolio & presentations: full GSK-ViiV LAI suite and oligonucleotide assets across lyophilized suspension, nanosuspension, solution, and powder in vial (PIV) ✓ Processes, platforms & tools: wet bead milling (WBM), mixing, filtration, filling, lyophilization; particulate control; PAT - Raman, NIR, NMR, UV; material-sparing predictive tools; process modeling PIV cross-portfolio capability workstream lead - Led PIV strategy for ViiV portfolio and built the capability from scratch on a compressed timeline, coordinated a complex supply chain across Pilot Plant, DPD, Quality, DSD, and Analytical. - Developed E2E particulate control strategy, secured stakeholder alignment for portfolio‑level execution. LAI PIV drug product workstream lead Process Engineering & Analytics (PE&A) lead: Oligonucleotide asset - Identified gaps in the incumbent mixing platform. Led evaluation, governance approval, and deployment of a new commercial system using characterization, surrogate/API‑sparing development, and modeling. - Deployed PAT for dissolution and pH. Coauthored control strategy, P2.3 and PAT PACMP for regulatory filing. Externalization, CDMO selection & delivery - Assessed CDMOs for manufacturing, recommended a suitable CDMO based on technical fit. - Defined process train, execution plan; led CMC and DPD LT alignment on capability gaps and delivery roadmap. Filling & Drying pillar co-lead: sMTT - steriles Manufacturing Technology Team, Pharma & Vaccines - Assigned and mentored 6 workstream leads; set priorities and drove execution through structured monthly governance. - Advanced platform technologies through the requisite MTT technical readiness levels (TRLs) and review process.
See under “Associate Director”
See under "Associate Director" In addition, Steriles & biopharm drug product modeling Lead - matrix team - Integrated Digital Design into sterile and biopharm product development, embedding “predict‑first” culture in teams. Material characterization workflow (MCW) - LAI suspensions - Led a cross-functional team to develop Materials Science Tetrahedron (MST) based material-sparing predictive tools now being integrated into early-molecule suitability framework for LAI. External collaborations lead - Industrial Advisory Board (IAB) Member and GSK Rep, CIMSEPP (Center of 10+ Pharma companies and 2 Universities). - GSK Rep, IQ consortium - Mat sci & modeling - Led collaborations with industries and academia.
• Established an integrated hot-melt extrusion - injection molding platform for continuous tablet manufacturing. • Studied formulation design space and critical process parameters required for the optimal performance of hot-melt extruded and injection molded tablets. • Analyzed potential coating polymers and process parameters suitable for the solvent-free injection coating technology. • Collaborated with interdisciplinary scientists from MIT & Novartis from Mechanical, modeling and automation fields, provided the required recommendations from process and formulation aspects.
Led pharmaceutical engineering projects related to granulation, milling, tableting and drug solubility enhancement.
PhD Project: “Study of disintegrants and disintegration phenomena” • Provided mechanistic understanding of the functionalities of the disintegrants by high speed video imaging and MATLAB image processing. • Innovated a responsive disintegration test apparatus using computational fluid dynamics and studied RDT disintegration phenomena using this fabricated apparatus. • Identified optimized blends of disintegrant polymers by Design of Experiments (DoE) and implemented Quality by Design (QbD) paradigm to formulate RDTs by direct compression technology. Received "Best Graduate Researcher Award" from Department of Pharmacy, National University of Singapore.
Teaching Assistant of the module PR4106-Dosage Form Design III, PR5218-Practical in product development. Responsible for handling lab sessions, evaluating examination papers, organizing tutorial sessions
Project 1: Investigating root causes of reduced API dissolution of tablet formulation Kepner-Tregoe analysis was performed and effects of operation process parameters and raw material attributes were analysed. Scatter plots, contour plots and multivariate data analysis study identified the root cause of the problem. Partial least square regression model was built to predict the API dissolution for future tablet batches. Project 2: Investigating root causes behind nip zone plugging issue during roller compaction process Evaluation of the flow properties of API powders using a powder rheometer identified that the cohesiveness of API powders was one of the root causes of the problem. Received “Award of Excellence” for excellent contributions and assistance to the company in short time period.