Shailaja Gupta, PhD

VP, Head of CMC

Shailaja joined Engitix in March 2026 as VP, Head of CMC, leading all aspects of Chemistry, Manufacturing, and Controls (CMC) to support the advancement of the company’s early-stage pipeline.

With over 20 years of experience across both emerging biotech and large pharmaceutical organizations, Shailaja brings deep expertise in CMC strategy, drug product development, and manufacturing across a broad range of modalities, including complex biologics, antibody-drug conjugates (ADCs), and small molecules.

Shailaja joins Engitix from Eli Lilly, where she led CMC drug product development and manufacturing for early-stage oncology programs,. In this role, she was responsible for advancing programs from candidate selection through proof-of-concept, while building effective development strategies and external manufacturing partnerships.

Prior to Lilly, Shailaja held leadership roles at Greenfire Bio, where she served as Head of CMC, as well as at Takeda and Johnson & Johnson. Throughout her career, she has successfully led cross-functional teams, managed global CDMO networks, and driven development programs from early stage through late-phase and commercial readiness. She has authored and contributed to numerous regulatory filings, including INDs, BLAs, and NDAs, supporting approvals of key therapies such as Sylvant® and Darzalex®.

Shailaja is widely recognized as an expert in lyophilisation and drug product development, along with experience in scientific leadership, operational excellence, and mentoring  teams.

She earned her PhD in Pharmaceutical Sciences from the University of Connecticut.