Manjeet Pimparade, PhD, PMP

• Owned end-to-end drug product and CMC strategy for a late-stage antiviral program (small molecule) using EMC platforms. • Directed scientific decision-making for formulation platform selection, evaluating manufacturability, release kinetics, stability, excipient compatibility, polymorphic behavior, dissolution/exposure relationships, and development risk. • Partnered with internal and external SMEs to establish IVIVC/IVIVR and PBPK-informed bioperformance models, using outputs to guide release specifications, formulation tradeoffs, and clinical design assumptions. • Designed late-stage development and commercialization transition activities, defining control strategy (CQAs, CMAs, CPPs), design space, validation framework (PPQ/PQ), and lifecycle quality plans aligned with ICH Q8–Q12. • Architected scale-up and tech transfer strategy from bench → pilot → commercial scale of hot melt extrusion, injection molding, and coating, including equipment comparability assessments and scale-dependent CPP controls. • Developed drug product-specific packaging, including moisture and oxygen barrier requirements, in-use stability, and patient usability. • Managed external CDMO/CRO partners, ensuring technical alignment and on-time deliverables. • Delivered ~90% reduction in cycle time and ~60% reduction in cost via process redesign while maintaining robustness and product performance. • Applied structured, risk-based development (DoE, FMEA, scale-up risk matrix) to evaluate tradeoffs between manufacturability, release performance, stability, and cost. • Led cross-functional alignment across DS, DP, Analytical, QA, Regulatory, Supply, PMO, and Clinical, coordinating CMC strategy, milestones, and global commercial planning. • Managed multi-asset antiviral portfolio development through formal CMC gates, ensuring transparent communication of technical risk, resource needs, and decision pathways to senior leadership

• CMC lead for Levomethadone HCl long-acting capsules, advancing from preclinical to Phase 1 clinical studies. • Directed manufacturing of 50+ GMP batches supporting Phase 1–3 clinical trials across multiple programs. • Scaled hot melt extrusion and coating processes across four stages (10g → 100g → 3kg → 25kg), implementing robust stage-appropriate process controls. • Authored CMC sections (3.2.P modules) for 3 IND submissions; executed deviation investigations and CAPAs. • Developed moisture control and packaging strategy for coated capsules, extending stability to meet commercial requirements. • Led CMO execution for late-stage DP manufacture, including tech transfer documentation, batch plans, deviation investigations, change control, and quality governance

• Reviewed proposals of early-stage/ start-up pharmaceutical and technological companies for investment • Performed scientific literature and patent search for team • Involved with company visits and product demonstrations

• Executed 20+ customer and internal development projects, developing formulations for poorly soluble APIs and novel excipients. • Contributed to 2 commercial product launches, translating lab innovations to market-ready products. • Led new excipient development team and collaborations with analytical, technical, and business teams. • Improved bioavailability through hot melt extrusion, spray drying, and drug layering technologies. • Conducted root cause investigations, process improvement, and early-stage company evaluations for venture investments.

• Formulated taste masked orally disintegration tablet (ODT) and orally disintegrating film (ODF) formulations utilizing hot melt extrusion technology and performed human taste panel evaluation • Formulated a pediatric-friendly taste masked reconstitutable Griseofulvin formulation • Developed multiparticulate floating dosages form utilizing a hot melt extruder • Studied the role of lipids in solubility enhancement for BCS class II drugs

• Evaluated the feasibility of 3D – printing & solvent casting methods for the development of implants • Worked on ionic liquids for bioavailability enhancement of poorly soluble API

• Executed various programs for the professional development of graduate students • Organize and lead a student committee for pharmacy education awareness • Collaborated with various UM student bodies for student events

• Outlined program ideas for the annual program • Served as a core member of the FDD committee • Chaired FDD student committee • Implemented mentorship- mentee program for graduate students

• Performed drug-polymer preformulation studies • Screened polymers for hot melt extrusion technology and developed high drug load amorphous solid dispersion utilizing hot melt extruder • Performed post extrusion in vitro and solid-state characterization using DSC, FTNIR, XRD, PLM, and SEM • Worked on twin screw granulation for high drug-loading API