Sandeep Kedia

Currently serving as Head of CMC and Asset Leader for clinical-stage therapeutic programs, providing end-to-end leadership across drug substance, drug product, analytical development, supply chain strategy, and regulatory CMC activities. Lead development of Target Product Profile (TPP)-aligned formulation strategies, including novel approaches to enable differentiated dosing and lifecycle value. Guide CDMO selection and oversight, technical development planning, control strategy development, IND-enabling readiness, and integrated asset strategy across clinical, regulatory, and commercial objectives.

Contribute to technical and CMC leadership to national initiatives aimed at strengthening biopharmaceutical development and manufacturing readiness. Apply deep industry experience to evaluate process maturity, analytical robustness, scalability, and CMC risk across a broad range of emerging technologies and development programs. Designed and advanced the Biomanufacturing Readiness Level (BRL) framework, now widely used to guide technology adoption and assess manufacturability. Collaborate with industry, academic, and federal partners to improve technical decision-making, promote practical implementation of new technologies, and support more efficient and reliable development pathways across the biomanufacturing ecosystem.

Provide strategic CMC leadership to emerging and venture-backed biopharma companies developing small-molecule therapeutics. Advise executive teams on development strategy, manufacturing readiness, regulatory planning, and technical risk as programs advance from early development through clinical readiness. Currently serving as fractional Head of CMC and asset leader for clinical-stage therapeutic programs, providing end-to-end leadership across drug substance, drug product, analytical development, supply chain strategy, and regulatory CMC activities. Lead development of Target Product Profile (TPP)-aligned formulation strategies, including novel approaches to enable differentiated dosing and lifecycle value. Guide CDMO selection and oversight, technical development planning, control strategy development, IND-enabling readiness, and integrated asset strategy across clinical, regulatory, and commercial objectives.

Led CMC strategy across development, manufacturing, and regulatory functions. Oversaw external manufacturing partners and supported global readiness activities for multiple pipeline and commercial programs. Partnered closely with Regulatory Affairs, Quality, and Supply Chain teams to ensure predictable execution and strong technical foundations. Worked across technical, clinical, and commercial partners to align CMC decisions with program objectives, timelines, and long-term supply needs.

Built and expanded a process development and engineering function supporting scale-up, analytical readiness, and manufacturing robustness. Guided DS and DP development activities, improved technical processes, and strengthened CDMO execution models for late-stage programs. Played a key role in connecting technical development work with broader program planning, ensuring that process decisions supported clinical needs, regulatory strategy, and downstream commercial requirements.

Supported development programs across multiple therapeutic areas with responsibility for DS/DP development, analytical alignment, control strategy, and global technical transfer. Worked closely with international regulatory and manufacturing partners to prepare assets for pivotal studies and commercial readiness. Collaborated across CMC, regulatory, clinical, and commercial teams to ensure that development, analytical, and manufacturing strategies were aligned with program goals and global launch expectations.